BLUE 400; BLUE 400 S— 510(k) K240215

Substantially Equivalent

Carl Zeiss Meditec, AG

FDA 510(k) clearance K240215 for BLUE 400; BLUE 400 S, Substantially Equivalent on 2024-06-28. 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: 2024-01-26
Decision date: 2024-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oberkochen, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QFX

K251286 — Affirm 4002026-01-21
K232567 — Myriad SPECTRA Light Source2024-03-14
K211346 — BLUE 4002022-07-22
DEN180024 — Leica FL4002019-03-28

More clearances from Carl Zeiss Meditec, AG

K260694 — ZEISS CLINIC 3602026-07-17
K241174 — INTRABEAM (700) +1 more2025-01-10
K233911 — VISULAS combi2024-09-06
K233421 — RESCAN 7002024-03-08
K232944 — CALLISTO eye2023-12-21

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