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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 K910223
Device Name CPI MODEL 2215/SEAMED MODEL 3400
Applicant
Seamed Corp.
11810 N. Creek Pkwy.
North
Bothell,  WA  98011
Applicant Contact KEITH PAYEA
Correspondent
Seamed Corp.
11810 N. Creek Pkwy.
North
Bothell,  WA  98011
Correspondent Contact KEITH PAYEA
Regulation Number870.3630
Classification Product Code
DTC  
Date Received01/18/1991
Decision Date 03/19/1991
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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