ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM— 510(k) K022164

Name: FDA 510(k) clearance K022164
Creator: U.S. Food and Drug Administration
Published: 2002-07-26

Substantially Equivalent

Zeta Development Laboratories

FDA 510(k) clearance K022164 for ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM, Substantially Equivalent on 2002-07-26. Applicant: Zeta Development Laboratories. Device class: 2.

Clearance details

Applicant: Zeta Development Laboratories
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2002-07-03
Decision date: 2002-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Dorado Hills, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKI

view all

K253176 — TearView2026-06-22
K251353 — Eyer 22026-01-16
K252120 — Fundus On Phone Non Mydriatic (FOP NM-10)2025-12-12
K250770 — Optina-4C (MHRC-C1N)2025-09-04
K243600 — 3nethra neo HD FA2025-08-14

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