FETASONDE LABOR STATUS DISPLAY

System, Monitoring, Perinatal

ROCHE MEDICAL ELECTRONICS, INC.

The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Fetasonde Labor Status Display.

Pre-market Notification Details

Device IDK791037
510k NumberK791037
Device Name:FETASONDE LABOR STATUS DISPLAY
ClassificationSystem, Monitoring, Perinatal
Applicant ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-05
Decision Date1979-09-04

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