MODEL 2106 FETA SONDE FETAL MONITOR

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 Model 2106 Feta Sonde Fetal Monitor.

Pre-market Notification Details

Device IDK760919
510k NumberK760919
Device Name:MODEL 2106 FETA SONDE FETAL MONITOR
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 Received1976-10-28
Decision Date1976-11-16

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