BLUE 400
K-Number: K211346 · 2022-07-22
ApplicantCarl Zeiss Meditec, AG
Decision Date2022-07-22
Product CodeQFX
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BLUE 400 is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2022-07-22 under approval number K211346. The device is classified under product code QFX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BLUE 400?
BLUE 400 is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K211346.
When was BLUE 400 approved by the FDA?
BLUE 400 received FDA 510(k) clearance on 2022-07-22, under approval number K211346.
What company makes BLUE 400?
BLUE 400 is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for BLUE 400?
The FDA product code for BLUE 400 is QFX.
Other Devices by Carl Zeiss Meditec, AG
Related Devices (Code: QFX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.