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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K013032
Device Name PHYSIOLOG, SERIES 95000
Applicant
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Applicant Contact SCOTT J PEASE
Correspondent
Camtronics, Ltd.
900 Walnut Ridge Dr.
P.O. Box 950
Hartland,  WI  53029
Correspondent Contact SCOTT J PEASE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received09/10/2001
Decision Date 06/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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