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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed doppler, ultrasonic
510(k) Number K014191
Device Name M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
Applicant
PHILIPS MEDICAL SYSTEMS
3000 MINUTEMAN RD.
ANDOVER,  MA  01810 -1099
Applicant Contact STEVE SINGLAR
Correspondent
TUV PRODUCT SERVICE, INC.
1775 OLD HIGHWAY 8
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact MARK JOB
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/21/2001
Decision Date 01/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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