The following data is part of a premarket notification filed by Leica Biosystems Richmond with the FDA for Leica Fl800.
| Device ID | K141136 |
| 510k Number | K141136 |
| Device Name: | LEICA FL800 |
| Classification | System, X-ray, Angiographic |
| Applicant | LEICA BIOSYSTEMS RICHMOND 5205 RT 12 Solon Mills, IL 60071 |
| Contact | Barbara-ann Conway-myers |
| Correspondent | Barbara-ann Conway-myers LEICA BIOSYSTEMS RICHMOND 5205 RT 12 Solon Mills, IL 60071 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-05-01 |
| Decision Date | 2014-08-19 |
| Summary: | summary |