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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K212291
Device Name PHOENIX
Applicant
Sedecal., Sa.
C/ Pelaya, 9 - 13 Pol. Ind. Río De Janeiro
Algete,  ES 28110
Applicant Contact Mª Luisa Gómez de Agüero
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1720
Classification Product Code
IZL  
Subsequent Product Code
MQB  
Date Received07/22/2021
Decision Date 09/14/2021
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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