NEONATAL PHYSIOLOGICAL MONITOR 903

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Neonatal Physiological Monitor 903.

Pre-market Notification Details

Device IDK840560
510k NumberK840560
Device Name:NEONATAL PHYSIOLOGICAL MONITOR 903
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-02-08
Decision Date1984-04-17

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