BLUE 400— 510(k) K211346

Substantially Equivalent

Carl Zeiss Meditec, AG

FDA 510(k) clearance K211346 for BLUE 400, Substantially Equivalent on 2022-07-22. Applicant: Carl Zeiss Meditec, AG. Device class: 2.

Clearance details

Applicant: Carl Zeiss Meditec, AG
Product code: Code QFX
Device class: Class 2
Regulation: 21 CFR 882.4950
Advisory panel: Neurology
Date received: 2021-05-03
Decision date: 2022-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jena, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFX

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DEN180024 — Leica FL4002019-03-28

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