MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY

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 Model 7000 Combination End Tidal & Pulse Oximetry.

Pre-market Notification Details

Device IDK874036
510k NumberK874036
Device Name:MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford,  CT  06492
ContactRobert E Yocher
CorrespondentRobert E Yocher
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 Received1987-10-05
Decision Date1987-11-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.