TCO2M MODEL 818

Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

NOVAMETRIX MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Tco2m Model 818.

Pre-market Notification Details

Device IDK791152
510k NumberK791152
Device Name:TCO2M MODEL 818
ClassificationMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Applicant NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLK  
CFR Regulation Number868.2500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-19
Decision Date1979-08-03

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