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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K964408
Device Name POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
Applicant
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Applicant Contact HERBERT J SEMLER, M.D.
Correspondent
Instromedix, Inc.
One Technology Center
7431 NE Evergreen Pkwy.
Hillsboro,  OR  97124
Correspondent Contact HERBERT J SEMLER, M.D.
Regulation Number870.2340
Classification Product Code
DPS  
Date Received11/04/1996
Decision Date 07/23/1997
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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