PENTACAM SCHEIMPFLUG CAMERA— 510(k) K030719

Name: FDA 510(k) clearance K030719
Creator: U.S. Food and Drug Administration
Published: 2003-09-16

Substantially Equivalent

Oculus Optikgerate GmbH

FDA 510(k) clearance K030719 for PENTACAM SCHEIMPFLUG CAMERA, Substantially Equivalent on 2003-09-16. Applicant: Oculus Optikgerate GmbH. Device class: 2.

Clearance details

Applicant: Oculus Optikgerate GmbH
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2003-03-07
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K030719

K-number listed on FDA's recall record

Z-1674-2022 — Pentacam HR REF 70900. Used to image the anterior segment of the eye.Class II·Ongoing·Oculus Optikgeraete GMBH·20220708

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030719.

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