ROCHE SENSOR ADAPTOR

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

ROCHE MEDICAL ELECTRONICS, INC.

The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Roche Sensor Adaptor.

Pre-market Notification Details

Device IDK791559
510k NumberK791559
Device Name:ROCHE SENSOR ADAPTOR
ClassificationMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Applicant ROCHE MEDICAL ELECTRONICS, 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 Received1979-08-17
Decision Date1979-11-21

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