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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 Echo, Ultrasonic
510(k) Number K170133
Device Name FFR V2.5
Applicant
Philips Volcano
3721 Valley Ctr. Dr.
San Diego,  CA  92130
Applicant Contact Elaine Alan
Correspondent
Philips Volcano
3721 Valley Ctr. Dr.
San Diego,  CA  92130
Correspondent Contact Elaine Alan
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/17/2017
Decision Date 05/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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