RESCAN 700, CALLISTO eye
K-Number: K180229 · 2019-01-11
ApplicantCarl Zeiss Meditec, AG
Decision Date2019-01-11
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
RESCAN 700, CALLISTO eye is a medical device manufactured by Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2019-01-11 under approval number K180229. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RESCAN 700, CALLISTO eye?
RESCAN 700, CALLISTO eye is a medical device that received FDA 510(k) clearance on 2019-01-11. It is manufactured by Carl Zeiss Meditec, AG. The 510(k) number is K180229.
When was RESCAN 700, CALLISTO eye approved by the FDA?
RESCAN 700, CALLISTO eye received FDA 510(k) clearance on 2019-01-11, under approval number K180229.
What company makes RESCAN 700, CALLISTO eye?
RESCAN 700, CALLISTO eye is manufactured by Carl Zeiss Meditec, AG.
What is the FDA product code for RESCAN 700, CALLISTO eye?
The FDA product code for RESCAN 700, CALLISTO eye is OBO.
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Official Source
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