Device Classification Name |
Interventional Fluoroscopic X-Ray System
|
510(k) Number |
K182086 |
Device Name |
ARCO FP |
Applicant |
A.T.S. Applicazione Tecnologie Speciali s.r.l. |
Via A. Volta, n.10 |
Torre de’ Roveri,
IT
24060
|
|
Applicant Contact |
Duilio Finazzi |
Correspondent |
Thema s.r.l. |
Via Saragat 5 |
Imola,
IT
40026
|
|
Correspondent Contact |
Marisa Testa |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2018 |
Decision Date | 08/20/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|