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

CATHETER, PO2, INTRAVASUCLAR, CITADEL

K Number: K771116 · Decision Sep 15, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
22
Applicant Total
62
Review Days
91

Basic Information

Device Name
CATHETER, PO2, INTRAVASUCLAR, CITADEL
K Number
K771116
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1200
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
SHERWOOD MEDICAL INDUSTRIES
Date Received
June 16, 1977
Decision Date
September 15, 1977
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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