The following data is part of a premarket notification filed by A.t.s. Applicazione Tecnologie Speciali S.r.l. with the FDA for Arco Fp.
| Device ID | K182086 |
| 510k Number | K182086 |
| Device Name: | ARCO FP |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | A.T.S. Applicazione Tecnologie Speciali S.r.l. Via A. Volta, N.10 Torre De’ Roveri, IT 24060 |
| Contact | Duilio Finazzi |
| Correspondent | Marisa Testa Thema S.r.l. Via Saragat 5 Imola, IT 40026 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-02 |
| Decision Date | 2019-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055186670242 | K182086 | 000 |
| 08055186670402 | K182086 | 000 |
| 08055186670419 | K182086 | 000 |
| 08055186670426 | K182086 | 000 |
| 08055186670334 | K182086 | 000 |
| 08055186670341 | K182086 | 000 |
| 08055186670358 | K182086 | 000 |
| 08055186670365 | K182086 | 000 |
| 08055186670112 | K182086 | 000 |
| 08055186670129 | K182086 | 000 |
| 08055186670136 | K182086 | 000 |
| 08055186670143 | K182086 | 000 |
| 08055186670211 | K182086 | 000 |
| 08055186670228 | K182086 | 000 |
| 08055186670235 | K182086 | 000 |
| 08055186670396 | K182086 | 000 |