The following data is part of a premarket notification filed by Quanta System, S.p.a with the FDA for Evo Platform.
| Device ID | K192160 |
| 510k Number | K192160 |
| Device Name: | EVO Platform |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Quanta System, S.p.A Via Acquedotto, 109 Samarate, IT 20826 |
| Contact | Francesco Dell'antonio |
| Correspondent | Francesco Dell'antonio Quanta System, S.p.A Via Acquedotto, 109 Samarate, IT 20826 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-09 |
| Decision Date | 2019-09-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08059173391875 | K192160 | 000 |
| 08059173391868 | K192160 | 000 |
| 08059173391851 | K192160 | 000 |
| 08059173391844 | K192160 | 000 |
| 08059173391837 | K192160 | 000 |
| 08059173391820 | K192160 | 000 |
| 08059173396368 | K192160 | 000 |