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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K071391
Device Name PHILIPS HEARTSTART 12 LEAD TRANSFER STATION, MODEL 989803142521
Applicant
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Applicant Contact PAUL SCHRADER
Correspondent
Philips Medical Systems, Inc.
3000 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact PAUL SCHRADER
Regulation Number870.2300
Classification Product Code
MSX  
Date Received05/18/2007
Decision Date 09/07/2007
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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