CAPNOXYGEN MASK

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

MEDSYS, INC.

The following data is part of a premarket notification filed by Medsys, Inc. with the FDA for Capnoxygen Mask.

Pre-market Notification Details

Device IDK971229
510k NumberK971229
Device Name:CAPNOXYGEN MASK
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant MEDSYS, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights,  NJ  07604
ContactGeorge Myers
CorrespondentGeorge Myers
MEDSYS, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights,  NJ  07604
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-02
Decision Date1997-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10620974001871 K971229 000
10620974001529 K971229 000
10620974001499 K971229 000
10620974001482 K971229 000
10620974001475 K971229 000

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