The following data is part of a premarket notification filed by Reichert Ophthalmic Instruments, Div. Leica, Inc. with the FDA for Reichert Ct200 Contact Tonometer.
| Device ID | K000288 |
| 510k Number | K000288 |
| Device Name: | REICHERT CT200 CONTACT TONOMETER |
| Classification | Tonometer, Manual |
| 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 | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-31 |
| Decision Date | 2000-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559010221 | K000288 | 000 |