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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 K930234
Device Name FLH1768M SERIES HOSPITAL BED
Applicant
Bertec Medical, Inc.
2155 Guy Stree
Suite 820
Montreal Canada,  CA H3H 2R9
Applicant Contact SYLVAIN BOUCHER
Correspondent
Bertec Medical, Inc.
2155 Guy Stree
Suite 820
Montreal Canada,  CA H3H 2R9
Correspondent Contact SYLVAIN BOUCHER
Regulation Number880.5100
Classification Product Code
FNL  
Date Received01/19/1993
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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