SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM

System, Ablation, Ultrasound And Accessories

MISONIX, INC.

The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Sonatherm 600i Ultrasonic Lesion Generating System.

Pre-market Notification Details

Device IDK070779
510k NumberK070779
Device Name:SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
ClassificationSystem, Ablation, Ultrasound And Accessories
Applicant MISONIX, INC. 1938 NEW HIGHWAY Farmingdale,  NY  11735
ContactRonald Manna
CorrespondentRonald Manna
MISONIX, INC. 1938 NEW HIGHWAY Farmingdale,  NY  11735
Product CodeNTB  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-21
Decision Date2008-07-09
Summary:summary

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