NOVAMETRIX MODEL 510

Oximeter

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Model 510.

Pre-market Notification Details

Device IDK924626
510k NumberK924626
Device Name:NOVAMETRIX MODEL 510
ClassificationOximeter
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford,  CT  06492
ContactRobert H Schiffman
CorrespondentRobert H Schiffman
NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford,  CT  06492
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-14
Decision Date1993-12-03

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