MODEL 20 DIGITAL PULSE RATE MONITOR

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

SENTRONIX, INC.

The following data is part of a premarket notification filed by Sentronix, Inc. with the FDA for Model 20 Digital Pulse Rate Monitor.

Pre-market Notification Details

Device IDK780937
510k NumberK780937
Device Name:MODEL 20 DIGITAL PULSE RATE MONITOR
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant SENTRONIX, 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 Received1978-06-08
Decision Date1978-08-31

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