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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name diathermy, shortwave, for use in applying therapeutic deep heat
510(k) Number K120093
Device Name BTL ELITE
Original Applicant
16 appleton street
waltham,  MA  02453
Original Contact marcy moore
Regulation Number890.5290
Classification Product Code
Date Received01/12/2012
Decision Date 10/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No