The following data is part of a premarket notification filed by Visionex, Inc. with the FDA for Tear Volume Tests.
| Device ID | K881515 |
| 510k Number | K881515 |
| Device Name: | TEAR VOLUME TESTS |
| Classification | Strip, Schirmer |
| Applicant | VISIONEX, INC. 1206 SARGENT DR. Sunnyvale, CA 94087 |
| Contact | Jessica Ayres |
| Correspondent | Jessica Ayres VISIONEX, INC. 1206 SARGENT DR. Sunnyvale, CA 94087 |
| Product Code | KYD |
| CFR Regulation Number | 886.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-05-23 |