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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K200603
Device Name AAA Model
Applicant
Philips Ultrasound, Inc
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Applicant Contact Hebe Sun
Correspondent
Philips Ultrasound, Inc
22100 Bothell Everett Highway
Bothell,  WA  98021 -8431
Correspondent Contact Hebe Sun
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/09/2020
Decision Date 09/20/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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