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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
510(k) Number K852746
Device Name EXTERNAL PACEMAKER TELECTRONICS TE200
Applicant
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Applicant Contact WILLIAM L SCOTT
Correspondent
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Correspondent Contact WILLIAM L SCOTT
Regulation Number870.1750
Classification Product Code
JOQ  
Date Received06/27/1985
Decision Date 09/12/1985
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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