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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 K944260
Device Name ECG ELECTRODE
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 Received08/30/1994
Decision Date 07/07/1995
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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