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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 K853705
Device Name BOMED-EEA
Applicant
Bomed Medical Mfr., Ltd.
5 Wrigley St.
Irvine,  CA  92714
Applicant Contact BO SRAMEK
Correspondent
Bomed Medical Mfr., Ltd.
5 Wrigley St.
Irvine,  CA  92714
Correspondent Contact BO SRAMEK
Regulation Number870.2360
Classification Product Code
DRX  
Date Received09/04/1985
Decision Date 01/13/1986
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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