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 |