The following data is part of a premarket notification filed by Oculab, Inc. with the FDA for Oculab Tonopen.
| Device ID | K852774 |
| 510k Number | K852774 |
| Device Name: | OCULAB TONOPEN |
| Classification | Tonometer, Manual |
| Applicant | OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Contact | David A Wallace |
| Correspondent | David A Wallace OCULAB, INC. 443 WEST COLORADO ST. Gendale, CA 91204 |
| Product Code | HKY |
| CFR Regulation Number | 886.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-01 |
| Decision Date | 1985-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812559010092 | K852774 | 000 |