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FDA 510(k)

RESCAN 700

K-Number: K233421 · 2024-03-08

ApplicantCarl Zeiss Meditec, AG
Decision Date2024-03-08
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RESCAN 700 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 2024-03-08 under 510(k) number K233421. 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?

RESCAN 700 is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K233421.

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

RESCAN 700 received FDA 510(k) clearance on 2024-03-08, under 510(k) number K233421.

Who is the listed applicant for RESCAN 700?

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?

The FDA product code for RESCAN 700 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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