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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 K842055
Device Name PICKER ARTIS ULTRASOUND IMAGING SYS
Applicant
Philips Medical Systems (Cleveland), Inc.
A
Cleveland,  OH  11111
Correspondent
Philips Medical Systems (Cleveland), Inc.
A
Cleveland,  OH  11111
Regulation Number892.1550
Classification Product Code
IYN  
Date Received05/22/1984
Decision Date 08/24/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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