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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K854734
Device Name MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
Applicant
Medasonics, Inc.
82 Pioneer Way
P.O. Box 7268
Mountain View,  CA  94042
Correspondent
Medasonics, Inc.
82 Pioneer Way
P.O. Box 7268
Mountain View,  CA  94042
Regulation Number870.5200
Classification Product Code
DRM  
Date Received11/25/1985
Decision Date 02/10/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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