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

VENOUS OXYGEN PROBE

K Number: K811071 · Decision May 5, 1981
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
22
Applicant Total
56
Review Days
15

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Basic Information

Device Name
VENOUS OXYGEN PROBE
K Number
K811071
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1200
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
G.D. Searle and Co.
Date Received
April 20, 1981
Decision Date
May 5, 1981
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 G.D. Searle and Co.

K Number Device Name
K821159 IN-LINE OXYGEN MONITORING SYSTEM
K811068 BYPASS COIL
K803238 INTRAVASCULAR CATHETER
K810630 SILICONE ELASTOMER COATED LATEX FOLEY
K810131 ADMINISTRATION SET
K802485 SEARLE VASCULAR LOOPS
K801805 METRONIDAZOLE DISCS
K810112 SWR DISPOSABLE PREP RAZOR
K802213 WHITE KNIGHT BOVIE CORD/SUCTION TUBE
K802280 WHITE KNIGHT DRAPE SEAL
Search all 56 clearances from G.D. Searle and Co. →