The following data is part of a premarket notification filed by Leica Microsystems (schweiz) Ag with the FDA for Leica Fl800.
| Device ID | K080612 |
| 510k Number | K080612 |
| Device Name: | LEICA FL800 |
| Classification | System, X-ray, Angiographic |
| Applicant | LEICA MICROSYSTEMS (SCHWEIZ) AG 1717 WEST COLLINS Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell LEICA MICROSYSTEMS (SCHWEIZ) AG 1717 WEST COLLINS Orange, CA 92867 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-04 |
| Decision Date | 2008-05-09 |
| Summary: | summary |