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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 K211777
Device Name ARCO FP-S
Applicant
A.T.S. Applicazione Tecnologie Speciali S.R.L.
Via Alessandro Volta, 10
Torre De Roveri,  IT 24060
Applicant Contact Livia Pillitteri
Correspondent
Kamm & Associates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
OXO  
Date Received06/09/2021
Decision Date 08/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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