The following data is part of a premarket notification filed by Micronica Srl with the FDA for C015.
| Device ID | K192182 |
| 510k Number | K192182 |
| Device Name: | C015 |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Micronica SRL Via Augusto Righi, 30 Mirandola, IT 41037 |
| Contact | Massimo Tomasi |
| Correspondent | Marisa Testa Thema S.r.l. Via Saragat,5 Imola, IT 40026 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | LMC |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2020-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08053470960017 | K192182 | 000 |
| 08053470960000 | K192182 | 000 |