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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, AG. It received FDA 510(k) clearance on 2019-01-11 under 510(k) 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. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K180229.

When did RESCAN 700, CALLISTO eye receive FDA 510(k) clearance?

RESCAN 700, CALLISTO eye received FDA 510(k) clearance on 2019-01-11, under 510(k) number K180229.

Who is the listed applicant for RESCAN 700, CALLISTO eye?

The FDA 510(k) record lists Carl Zeiss Meditec, AG as the applicant. This does not by itself establish the device manufacturer.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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