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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bed, Manual
510(k) Number K812600
Device Name GER 540, GER 541 MANUAL BED
Applicant
G.W. Healthcare, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
G.W. Healthcare, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5120
Classification Product Code
FNJ  
Date Received09/14/1981
Decision Date 09/23/1981
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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