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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name interventional fluoroscopic x-ray system
510(k) Number K191503
Device Name MobileRay Pulse SE Digital Imaging System
Applicant
Portavision Medical LLC
800 Central Avenue
Jefferson,  LA  70121
Applicant Contact Terry Ancar
Correspondent
Kamm & Associates
8870 Ravello Court
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received06/06/2019
Decision Date 09/04/2019
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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