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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Hydraulic, Adjustable Hospital
510(k) Number K944929
Device Name OPTIMA DELIVERY BED (MODELS 33901, 33903, 33902, 33905)
Applicant
Merivaara Instrumentarium Corp.
Fin-15150
Lahti,  FI 15150
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Merivaara Instrumentarium Corp.
Fin-15150
Lahti,  FI 15150
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number880.5110
Classification Product Code
FNK  
Date Received10/06/1994
Decision Date 11/22/1994
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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