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-s.
| Device ID | K211777 |
| 510k Number | K211777 |
| Device Name: | ARCO FP-S |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | A.T.S. Applicazione Tecnologie Speciali S.R.L. Via Alessandro Volta, 10 Torre De Roveri, IT 24060 |
| Contact | Livia Pillitteri |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | OWB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-09 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08055186670327 | K211777 | 000 |
| 08055186670310 | K211777 | 000 |
| 08055186670303 | K211777 | 000 |
| 08055186670297 | K211777 | 000 |
| 08055186670389 | K211777 | 000 |
| 08055186670372 | K211777 | 000 |
| 08055186670440 | K211777 | 000 |
| 08055186670433 | K211777 | 000 |