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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K944496
Device Name BIOTRACE-N, NS, 410 AND RT
Applicant
Msb , Ltd.
Hilldrop Lane, Ramsbury
Marlborough, Wiltshire,  GB SN8 2RB
Applicant Contact MARTIN BEAUMONT
Correspondent
Msb , Ltd.
Hilldrop Lane, Ramsbury
Marlborough, Wiltshire,  GB SN8 2RB
Correspondent Contact MARTIN BEAUMONT
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/13/1994
Decision Date 05/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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