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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 K926045
Device Name SKYTRON LIFE ISLAND 21
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Applicant Contact DAVID M MEHNEY
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St., SE
Grand Rapids,  MI  49512
Correspondent Contact DAVID M MEHNEY
Regulation Number880.5550
Classification Product Code
FNM  
Date Received12/01/1992
Decision Date 07/27/1993
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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