MODEL 520A NOVAMETRIX PULSE OXIMETER

Oximeter

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Model 520a Novametrix Pulse Oximeter.

Pre-market Notification Details

Device IDK913516
510k NumberK913516
Device Name:MODEL 520A NOVAMETRIX PULSE OXIMETER
ClassificationOximeter
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 1 BARNES INDUSTRIAL PARK RD. P.O. BOX 690 Wallingford,  CT  06492
ContactRobert Schiffman
CorrespondentRobert 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 Received1991-08-07
Decision Date1991-11-04

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