HETERODYNAMIC

Stimulator, Muscle, Powered

BIRTCHER CORP.

The following data is part of a premarket notification filed by Birtcher Corp. with the FDA for Heterodynamic.

Pre-market Notification Details

Device IDK821157
510k NumberK821157
Device Name:HETERODYNAMIC
ClassificationStimulator, Muscle, Powered
Applicant BIRTCHER CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-04-22
Decision Date1982-06-23

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