BLUE 400; BLUE 400 S
K-Number: K240215 · 2024-06-28
ApplicantCarl Zeiss Meditec, AG
Decision Date2024-06-28
Product CodeQFX
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
BLUE 400; BLUE 400 S is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2024-06-28 under approval number K240215. 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 S?
BLUE 400; BLUE 400 S is a medical device that received FDA 510(k) clearance on 2024-06-28. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K240215.
When was BLUE 400; BLUE 400 S approved by the FDA?
BLUE 400; BLUE 400 S received FDA 510(k) clearance on 2024-06-28, under approval number K240215.
What company makes BLUE 400; BLUE 400 S?
BLUE 400; BLUE 400 S is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for BLUE 400; BLUE 400 S?
The FDA product code for BLUE 400; BLUE 400 S 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.