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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Ac-Powered Adjustable Hospital
510(k) Number K925534
Device Name FULL/SEMI ELECTRIC HOME CARE BED
Applicant
IVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
IVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number880.5100
Classification Product Code
FNL  
Date Received11/02/1992
Decision Date 05/12/1993
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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