Atlas FDA

VANGUARD REPROCESSED PULSE OXIMETER SENSORS

FDA 510(k) clearance K012344 · decided 2002-10-04

Clearance details

K-number
K012344
Device name
VANGUARD REPROCESSED PULSE OXIMETER SENSORS
Applicant
Vanguard Medical Concepts, Inc.
Decision
Substantially Equivalent
Date received
2001-07-24
Decision date
2002-10-04
Days to decision
437 days
Clearance type
Traditional
Product code
NLF
Device class
2
Regulation number
870.2700
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lakeland, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device -- Pulse recall (Z-1663-2008)Ascent Healthcare Solutions, Inc.2008-09-19
Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. recall (Z-1664-2008)Ascent Healthcare Solutions, Inc.2008-09-19
Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. recall (Z-1683-2008)Ascent Healthcare Solutions, Inc.2008-09-19