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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Air Fluidized
510(k) Number K870045
Device Name SKYTRON MODEL 610-2
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Applicant Contact LARRY J PURCEY
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Correspondent Contact LARRY J PURCEY
Regulation Number890.5160
Classification Product Code
INX  
Date Received01/05/1987
Decision Date 02/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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