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

OXYGEN ANALYZER 110

K Number: K780185 · Decision Mar 17, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
66
Review Days
39

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Basic Information

Device Name
OXYGEN ANALYZER 110
K Number
K780185
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1150
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Siemens Corp.
Date Received
February 6, 1978
Decision Date
March 17, 1978
Product Code
CCC
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
CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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