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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mattress, Air Flotation, Alternating Pressure
510(k) Number K941083
Device Name DYNAMEDICS ASAR
Applicant
Dynamedics Corporation
30 Adelaide St. N., #205
London, Ontario,  CA N6B 3N5
Applicant Contact STEPHEN MATHESON
Correspondent
Dynamedics Corporation
30 Adelaide St. N., #205
London, Ontario,  CA N6B 3N5
Correspondent Contact STEPHEN MATHESON
Regulation Number880.5550
Classification Product Code
FNM  
Date Received03/08/1994
Decision Date 01/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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