GENERATOR, R-WAVE

Synchronizer, Electrocardiograph, Nuclear

AMR CO.

The following data is part of a premarket notification filed by Amr Co. with the FDA for Generator, R-wave.

Pre-market Notification Details

Device IDK790213
510k NumberK790213
Device Name:GENERATOR, R-WAVE
ClassificationSynchronizer, Electrocardiograph, Nuclear
Applicant AMR CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIYY  
CFR Regulation Number892.1410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-01-30
Decision Date1979-03-22

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