THE CRITERION II PACING SYS. MONITOR

Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

DART MEDICAL EQUIPMENT

The following data is part of a premarket notification filed by Dart Medical Equipment with the FDA for The Criterion Ii Pacing Sys. Monitor.

Pre-market Notification Details

Device IDK802782
510k NumberK802782
Device Name:THE CRITERION II PACING SYS. MONITOR
ClassificationMonitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Applicant DART MEDICAL EQUIPMENT 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 Received1980-11-03
Decision Date1980-11-19

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