FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100

K Number: K872896 · Decision Feb 12, 1988
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
22
Applicant Total
59
Review Days
204

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Basic Information

Device Name
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
K Number
K872896
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1200
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
American Bentley
Date Received
July 23, 1987
Decision Date
February 12, 1988
Product Code
CCE
Advisory Committee
Anesthesiology
Review Advisory Committee
AN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

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Other Clearances by American Bentley

K Number Device Name
K873923 INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K872167 CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K870804 CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K872133 OXYGENATOR MODEL NO. BENTLEY 5 PLUS
K870911 INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870269 ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
K863249 OXYGENATOR MODEL NO. BENTLEY-10 PLUS
K861641 HEPARIN-COATED EXTRACORPOREAL CIRCUITS
K862549 ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K860673 OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B
Search all 59 clearances from American Bentley →