The following data is part of a premarket notification filed by Leica Microsystems (schweiz) Ag with the FDA for Glow800.
| Device ID | K181537 |
| 510k Number | K181537 |
| Device Name: | GLOW800 |
| Classification | System, X-ray, Angiographic |
| Applicant | Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 Heerbrugg, CH 9435 |
| Contact | Georges Hakim |
| Correspondent | Georges Hakim Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 Heerbrugg, CH 9435 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2018-06-11 |
| Decision Date | 2018-09-07 |
| Summary: | summary |