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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Miniature Pressure
510(k) Number K875103
Device Name BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1
Applicant
Shield Computers , Ltd.
John St.
Barnsley S70 1ll,  GB
Applicant Contact BELL
Correspondent
Shield Computers , Ltd.
John St.
Barnsley S70 1ll,  GB
Correspondent Contact BELL
Regulation Number890.1615
Classification Product Code
IKE  
Date Received12/10/1987
Decision Date 01/20/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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