The following data is part of a premarket notification filed by Leica Microsystems, Inc. with the FDA for Leica Model Fl800.
| Device ID | K061871 |
| 510k Number | K061871 |
| Device Name: | LEICA MODEL FL800 |
| Classification | System, X-ray, Angiographic |
| Applicant | LEICA MICROSYSTEMS, INC. 2337 LUCKY JOHN DRIVE Park City, UT 84060 |
| Contact | Max Sturgis |
| Correspondent | Max Sturgis LEICA MICROSYSTEMS, INC. 2337 LUCKY JOHN DRIVE Park City, UT 84060 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-03 |
| Decision Date | 2006-09-20 |
| Summary: | summary |