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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Lead Switching, Electrocardiograph
510(k) Number K872781
Device Name EASI LEAD SYSTEM CABLE ASSEMBLY
Applicant
Totemite Medical Electronics
Box F110-232
264 "H" St.
Blaine,  WA  98230
Applicant Contact DOWER, M.D.
Correspondent
Totemite Medical Electronics
Box F110-232
264 "H" St.
Blaine,  WA  98230
Correspondent Contact DOWER, M.D.
Regulation Number870.2350
Classification Product Code
DRW  
Date Received07/14/1987
Decision Date 12/29/1987
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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