RetCam Envision— 510(k) K203500

Name: FDA 510(k) clearance K203500
Creator: U.S. Food and Drug Administration
Published: 2021-04-13

Substantially Equivalent

Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

FDA 510(k) clearance K203500 for RetCam Envision, Substantially Equivalent on 2021-04-13. Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Device class: 2.

Clearance details

Applicant: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 2020-11-30
Decision date: 2021-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakville, CA

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

More clearances from Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

view all

K242930 — Natus BrainWatch System2024-11-19
K233649 — ALGO Pro Newborn Hearing Screener (ALGO Pro)2024-03-08
K200878 — Natus NeuroWorks2020-05-18
K173936 — Natus Photic Stimulator2018-06-15
K180290 — Natus Brain Monitor Amplifier2018-06-14

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