The following data is part of a premarket notification filed by General Medical Merate S.p.a with the FDA for Mecall Clisis Systems, Discovery Rf180.
| Device ID | K173395 |
| 510k Number | K173395 |
| Device Name: | MECALL CLISIS SYSTEMS, Discovery RF180 |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | General Medical Merate S.P.A Via Partigiani, 25 Seriate, IT 24068 |
| Contact | Luca Bianchessi |
| Correspondent | Marisa Testa Thema SRL Via Saragat 5 Imola, IT 40026 |
| Product Code | JAA |
| Subsequent Product Code | IZI |
| Subsequent Product Code | KXJ |
| Subsequent Product Code | MQB |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-30 |
| Decision Date | 2018-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08054890480154 | K173395 | 000 |
| 08054890480178 | K173395 | 000 |
| 08054890480185 | K173395 | 000 |
| 08054890480024 | K173395 | 000 |
| 08054890480055 | K173395 | 000 |
| 08054890480062 | K173395 | 000 |
| 08054890480079 | K173395 | 000 |
| 08054890480086 | K173395 | 000 |
| 08054890480093 | K173395 | 000 |
| 08054890480109 | K173395 | 000 |
| 08054890480116 | K173395 | 000 |
| 08054890480123 | K173395 | 000 |
| 08054890480130 | K173395 | 000 |
| 08054890480147 | K173395 | 000 |
| 08054890480161 | K173395 | 000 |