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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 K113144
Device Name PAGEWRITER TC 20, 30, 50, 70
Applicant
Philips Medical Systems
3000 Minuteman Rd.
Andover,  MA  01810 -1099
Applicant Contact PAUL SCHRADER
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact DAWN TIBODEAU
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/25/2011
Decision Date 04/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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