MONITOR, HEART RATE MODEL 105

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

ROCHE MEDICAL ELECTRONICS, INC.

The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Monitor, Heart Rate Model 105.

Pre-market Notification Details

Device IDK782088
510k NumberK782088
Device Name:MONITOR, HEART RATE MODEL 105
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-12-14
Decision Date1979-01-04

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