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FDA 510(k)

BLUE 400

K-Number: K211346 · 2022-07-22

ApplicantCarl Zeiss Meditec, AG
Decision Date2022-07-22
Product CodeQFX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BLUE 400 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 2022-07-22 under 510(k) number K211346. 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 is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Carl Zeiss Meditec, AG. The 510(k) number is K211346.

When did BLUE 400 receive FDA 510(k) clearance?

BLUE 400 received FDA 510(k) clearance on 2022-07-22, under 510(k) number K211346.

Who is the listed applicant for BLUE 400?

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 BLUE 400?

The FDA product code for BLUE 400 is QFX.

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Other records listing Carl Zeiss Meditec, AG as applicant

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Related Devices (Code: QFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251286Affirm 400Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K240215BLUE 400; BLUE 400 SCarl Zeiss Meditec, AGK232567Myriad SPECTRA Light SourceNico Corporation

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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