DYNASOUND 601

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

DYNAWAVE, CORP.

The following data is part of a premarket notification filed by Dynawave, Corp. with the FDA for Dynasound 601.

Pre-market Notification Details

Device IDK791976
510k NumberK791976
Device Name:DYNASOUND 601
ClassificationUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Applicant DYNAWAVE, CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeIMI  
CFR Regulation Number890.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-10-02
Decision Date1980-01-09

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