The following data is part of a premarket notification filed by Reichert Inc. with the FDA for Non-contact Tonometers, Ocular Response Analyzer.
| Device ID | K032799 |
| 510k Number | K032799 |
| Device Name: | NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER |
| Classification | Tonometer, Ac-powered |
| Applicant | REICHERT INC. 3374 WALDEN AVE. Depew, NY 14043 |
| Contact | Frank Drexelius |
| Correspondent | Frank Drexelius REICHERT 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 | 2003-09-09 |
| Decision Date | 2004-01-20 |