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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 K221803
Device Name PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.
Applicant
Sedecal., Sa.
C/ Pelaya, 9 – 13 Pol. Ind. Río De Janeiro
Algete,  ES 28110
Applicant Contact Ma Luisa Gomez de Aguero
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 Received06/22/2022
Decision Date 07/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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