TRU-VIEW MULTI-CHANNEL DISPLAY

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

GENERAL DEVICES

The following data is part of a premarket notification filed by General Devices with the FDA for Tru-view Multi-channel Display.

Pre-market Notification Details

Device IDK912008
510k NumberK912008
Device Name:TRU-VIEW MULTI-CHANNEL DISPLAY
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
ContactMichael Smith
CorrespondentMichael Smith
GENERAL DEVICES 190 LEONIA AVE. Bogota,  NJ  07603
Product CodeDRT  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-06
Decision Date1991-10-09

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