The following data is part of a premarket notification filed by Reichert Ophthalmic Instruments, Div. Leica, Inc. with the FDA for Xpert Nct.
| Device ID | K941865 |
| 510k Number | K941865 |
| Device Name: | XPERT NCT |
| Classification | Tonometer, Ac-powered |
| Applicant | REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. 3374 WALDEN AVE. Depew, NY 14043 |
| Contact | Frank J Drexelius |
| Correspondent | Frank J Drexelius REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC. 3374 WALDEN AVE. Depew, NY 14043 |
| Product Code | HKX |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-18 |
| Decision Date | 1994-09-29 |