The following data is part of a premarket notification filed by Reichert, Inc. with the FDA for Xcel 455 Slit Lamp.
| Device ID | K141954 |
| 510k Number | K141954 |
| Device Name: | XCEL 455 SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | REICHERT, INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Contact | Thomas M Heckmann |
| Correspondent | Thomas M Heckmann REICHERT, INC. 3362 WALDEN AVE. Depew, NY 14043 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-18 |
| Decision Date | 2014-10-15 |
| Summary: | summary |