COSMO PLUS WITH NICO, MODEL 8200

Calculator, Pulmonary Function Data

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Cosmo Plus With Nico, Model 8200.

Pre-market Notification Details

Device IDK982499
510k NumberK982499
Device Name:COSMO PLUS WITH NICO, MODEL 8200
ClassificationCalculator, Pulmonary Function Data
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford,  CT  06492
ContactRobert H Schiffman
CorrespondentRobert H Schiffman
NOVAMETRIX MEDICAL SYSTEMS, INC. 56 CARPENTER LN. Wallingford,  CT  06492
Product CodeBZC  
CFR Regulation Number868.1880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-20
Decision Date1998-10-16

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