The following data is part of a premarket notification filed by Leica Microsystems (schweiz) Ag with the FDA for Leica Fl560.
| Device ID | K170239 |
| 510k Number | K170239 |
| Device Name: | Leica FL560 |
| Classification | System, X-ray, Angiographic |
| Applicant | LEICA MICROSYSTEMS (SCHWEIZ) AG MAX SCHMIDHEINY-STRASSE 201 Heerbrugg, CH 9435 |
| Contact | Grainne Griffin |
| Correspondent | Grainne Griffin LEICA MICROSYSTEMS (SCHWEIZ) AG MAX SCHMIDHEINY-STRASSE 201 Heerbrugg, CH 9435 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2017-01-26 |
| Decision Date | 2017-07-05 |
| Summary: | summary |