SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

HENLEY INTL.

The following data is part of a premarket notification filed by Henley Intl. with the FDA for Sonopuls 463, Ultrasound Therapy Equipment.

Pre-market Notification Details

Device IDK872393
510k NumberK872393
Device Name:SONOPULS 463, ULTRASOUND THERAPY EQUIPMENT
ClassificationUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Applicant HENLEY INTL. 10518 KINGHURST Houston,  TX  77099
ContactHenley, Phd
CorrespondentHenley, Phd
HENLEY INTL. 10518 KINGHURST Houston,  TX  77099
Product CodeIMI  
CFR Regulation Number890.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-12
Decision Date1987-07-23

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