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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 K212777
Device Name Collaboration Live
Applicant
Philips Ultrasound, Inc.
22100 Bothell Everett Highway
Bothell,  WA  98201 -8431
Applicant Contact Courtney Nix
Correspondent
Philips Ultrasound, Inc
22100 Bothell Everett Highway
Bothell,  WA  98201 -8432
Correspondent Contact Tamara Daniels
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Codes
IYN   IYO  
Date Received09/01/2021
Decision Date 09/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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