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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K952328
Device Name NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
Applicant
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Applicant Contact LAUREN L FOOTE CHRISTENSEN
Correspondent
Biotronik, Inc.
6024 Jean Rd.
Lake Oswego,  OR  97035
Correspondent Contact LAUREN L FOOTE CHRISTENSEN
Regulation Number870.3610
Classification Product Code
DXY  
Date Received05/18/1995
Decision Date 09/29/1995
Decision SE SUBJECT TO TRACKING REG (ST)
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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