Eyer Retinal Camera NM-STD— 510(k) K221329

Name: FDA 510(k) clearance K221329
Creator: U.S. Food and Drug Administration
Published: 2023-02-22

Substantially Equivalent

Phelcom Technologies

FDA 510(k) clearance K221329 for Eyer Retinal Camera NM-STD, Substantially Equivalent on 2023-02-22. Applicant: Phelcom Technologies. Device class: 2.

Clearance details

Applicant: Phelcom Technologies
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2022-05-06
Decision date: 2023-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: São Carlos, BR

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.