EYECHEK
Keratoscope, Ac-powered
REICHERT OPHTHALMIC INSTRUMENTS, DIV. LEICA, INC.
The following data is part of a premarket notification filed by Reichert Ophthalmic Instruments, Div. Leica, Inc. with the FDA for Eyechek.
Pre-market Notification Details
| Device ID | K964290 |
| 510k Number | K964290 |
| Device Name: | EYECHEK |
| Classification | Keratoscope, 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 | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-28 |
| Decision Date | 1997-01-09 |
Trademark Results [EYECHEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EYECHEK 75399119 not registered Dead/Abandoned |
Leica Inc. 1997-12-03 |
 EYECHEK 74704602 not registered Dead/Abandoned |
LEICA INC. 1995-07-24 |
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