CALLISTO eye
K-Number: K180858 · 2018-06-27
ApplicantCarl Zeiss Meditec, AG
Decision Date2018-06-27
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
CALLISTO eye is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2018-06-27 under approval number K180858. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CALLISTO eye?
CALLISTO eye is a medical device that received FDA 510(k) clearance on 2018-06-27. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K180858.
When was CALLISTO eye approved by the FDA?
CALLISTO eye received FDA 510(k) clearance on 2018-06-27, under approval number K180858.
What company makes CALLISTO eye?
CALLISTO eye is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for CALLISTO eye?
The FDA product code for CALLISTO eye is NFJ.
Other Devices by Carl Zeiss Meditec, AG
Related Devices (Code: NFJ)
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.