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

SIEMENS ETCO2 CARTRIDGE

K Number: K905775 · Decision Mar 11, 1991
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
15
Review Days
74

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Basic Information

Device Name
SIEMENS ETCO2 CARTRIDGE
K Number
K905775
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
868.1400
Medical Specialty
Anesthesiology
Decision
Substantially Equivalent
Applicant
Siemens Medical Electronics
Date Received
December 27, 1990
Decision Date
March 11, 1991
Product Code
CCK
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
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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K894460 SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA
K891481 SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
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