Atlas FDA

BCI ADVISOR VITAL SIGNS MONITOR (9200)

FDA 510(k) clearance K010770 · decided 2001-06-12

Clearance details

K-number
K010770
Device name
BCI ADVISOR VITAL SIGNS MONITOR (9200)
Applicant
Bci, Inc.
Decision
Substantially Equivalent
Date received
2001-03-14
Decision date
2001-06-12
Days to decision
90 days
Clearance type
Traditional
Product code
MWI
Device class
2
Regulation number
870.2300
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 9206542 recall (Z-1326-2009)Smiths Medical PM, Inc.2009-05-15
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200) recall (Z-1089-2007)Smiths Medical PM, Inc.2007-07-23
Advisor Vital Signs Monitor (model 9200), catalog number 920634235, with Impedance Respira recall (Z-0220-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 920654230, with Impedance Respira recall (Z-0221-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), Catalog number 920654235, with Impedance Respira recall (Z-0222-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 920654335, with Impedance Respira recall (Z-0223-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 920655235, with Impedance Respira recall (Z-0224-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 920754235, with Impedance Respira recall (Z-0225-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925454220, with Impedance Respira recall (Z-0226-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925454225, with Impedance Respira recall (Z-0227-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925454325, with Impedance Respira recall (Z-0228-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925454335, with Impedance Respira recall (Z-0229-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925474335, with Impedance Respira recall (Z-0230-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925534325, with Impedance Respira recall (Z-0231-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925654320, with Impedance Respira recall (Z-0232-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925654335, with Impedance Respira recall (Z-0233-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925674325, with Impedance Respira recall (Z-0234-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925754220, with Impedance Respira recall (Z-0235-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925754225, with Impedance Respira recall (Z-0236-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 925754325, with Impedance Respira recall (Z-0237-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 92D654335, with Impedance Respira recall (Z-0238-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 92D754335, with Impedance Respira recall (Z-0239-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200), catalog number 92E654335, with Impedance Respira recall (Z-0240-06)Smiths Medical PM, Inc.2005-11-30
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0824-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0825-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0826-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0827-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0828-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0829-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0830-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0831-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0832-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0833-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0834-05)Smiths Medical PM, Inc.2005-05-12
Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S o recall (Z-0835-05)Smiths Medical PM, Inc.2005-05-12