ANISEIKONIA INSPECTOR— 510(k) K013110

Name: FDA 510(k) clearance K013110
Creator: U.S. Food and Drug Administration
Published: 2001-12-19

Substantially Equivalent

Optical Diagnostics, Inc.

FDA 510(k) clearance K013110 for ANISEIKONIA INSPECTOR, Substantially Equivalent on 2001-12-19. Applicant: Optical Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Optical Diagnostics, Inc.
Product code: Code HJT
Device class: Class 1
Regulation: 21 CFR 886.1340
Advisory panel: Ophthalmic
Date received: 2001-07-11
Decision date: 2001-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issaquah, WA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HJT

view all

K012530 — AA-1 SYSTEM2001-08-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.