The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Proview Eye Pressure Monitor.
| Device ID | K011199 |
| 510k Number | K011199 |
| Device Name: | PROVIEW EYE PRESSURE MONITOR |
| Classification | Tonometer, Manual |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Douglas J Fortunato |
| Correspondent | Douglas J Fortunato BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-07-02 |