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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Pacemaker Generator Function
510(k) Number K860462
Device Name SEAMED MODEL 3000
Applicant
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Applicant Contact DANIEL L ROPER
Correspondent
Seamed Corp.
4500-150th. Ave. NE
Redmond,  WA  98052
Correspondent Contact DANIEL L ROPER
Regulation Number870.3630
Classification Product Code
DTC  
Date Received02/06/1986
Decision Date 08/19/1986
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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