OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN— 510(k) K092374

Substantially Equivalent

Ophthalmic Imaging Systems

FDA 510(k) clearance K092374 for OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN, Substantially Equivalent on 2009-11-17. Applicant: Ophthalmic Imaging Systems. Device class: 2.

Clearance details

Applicant
Ophthalmic Imaging Systems
Product code
Code HKI
Device class
Class 2
Regulation
21 CFR 886.1120
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sacramento, CA, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code HKI

view all

More clearances from Ophthalmic Imaging Systems

view all

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