TRANSCUTANEOUS 800-OXYGEN MONITORS/801

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 Transcutaneous 800-oxygen Monitors/801.

Pre-market Notification Details

Device IDK840993
510k NumberK840993
Device Name:TRANSCUTANEOUS 800-OXYGEN MONITORS/801
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 Received1984-03-08
Decision Date1984-04-24

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