CPNOGARD CAPNOMETER 1250

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Cpnogard Capnometer 1250.

Pre-market Notification Details

Device IDK844010
510k NumberK844010
Device Name:CPNOGARD CAPNOMETER 1250
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford,  CT  06492
ContactPaul V Buday
CorrespondentPaul V Buday
NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford,  CT  06492
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-10-12
Decision Date1985-02-21

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