The following data is part of a premarket notification filed by Optical Diagnostics, Inc. with the FDA for Aniseikonia Inspector.
Device ID | K013110 |
510k Number | K013110 |
Device Name: | ANISEIKONIA INSPECTOR |
Classification | Haploscope |
Applicant | OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW Issaquah, WA 98027 |
Contact | Joyce De Wit |
Correspondent | Joyce De Wit OPTICAL DIAGNOSTICS, INC. 490 MT. FURY CIRCLE SW Issaquah, WA 98027 |
Product Code | HJT |
CFR Regulation Number | 886.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-11 |
Decision Date | 2001-12-19 |
Summary: | summary |