Atlas FDA

NICO WITH MARS, MODEL 7300

FDA 510(k) clearance K030886 · decided 2003-10-07

Clearance details

K-number
K030886
Device name
NICO WITH MARS, MODEL 7300
Applicant
Respironics Novametrix, Inc.
Decision
Substantially Equivalent
Date received
2003-03-21
Decision date
2003-10-07
Days to decision
200 days
Clearance type
Traditional
Product code
CCK
Device class
2
Regulation number
868.1400
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Wallingford, CT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
NICO2, Model 7600 Respironics/Philips Product. Intended use is cardiac output monitoring v recall (Z-1262-2010)Philips Healthcare Inc.2010-04-08
100-120V NICO, 7300 Cardio Mgt system, Respironics/Philips product. Intended use is cardia recall (Z-1280-2010)Philips Healthcare Inc.2010-04-08
French 100-120V NICO 7300, Respironics/Philips product. Intended use is: cardiac output mo recall (Z-1281-2010)Philips Healthcare Inc.2010-04-08
Spanish 100-120V NICO 7300, Respironics/Philips product. Intended use is cardiac output mo recall (Z-1282-2010)Philips Healthcare Inc.2010-04-08
NIC02 Model 7600 Demo Unit, Respironics/Philips product. Intended use is cardiac output mo recall (Z-1284-2010)Philips Healthcare Inc.2010-04-08
NIC02 Model 7600 Refurbished, Respironics/Philips product. Intended use is cardiac output recall (Z-1285-2010)Philips Healthcare Inc.2010-04-08
100-200V NICO, 7300 Cardio Mgt System, Refurbished, Respironics/Philips product. The inten recall (Z-1293-2010)Philips Healthcare Inc.2010-04-08
NICO Model 7300 Cardiopulmonary Management System recall (Z-1535-06)Respironics Novametrix, LLC.2006-09-29