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FDA 510(k)

CIRRUS™ HD-OCT Model 6000

K-Number: K233933 · 2024-05-17

ApplicantCarl Zeiss Meditec, Inc.
Decision Date2024-05-17
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CIRRUS™ HD-OCT Model 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec, Inc.. It received FDA 510(k) clearance on 2024-05-17 under 510(k) number K233933. 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 CIRRUS™ HD-OCT Model 6000?

CIRRUS™ HD-OCT Model 6000 is a medical device that received FDA 510(k) clearance on 2024-05-17. The listed applicant is Carl Zeiss Meditec, Inc.. The 510(k) number is K233933.

When did CIRRUS™ HD-OCT Model 6000 receive FDA 510(k) clearance?

CIRRUS™ HD-OCT Model 6000 received FDA 510(k) clearance on 2024-05-17, under 510(k) number K233933.

Who is the listed applicant for CIRRUS™ HD-OCT Model 6000?

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

What is the FDA product code for CIRRUS™ HD-OCT Model 6000?

The FDA product code for CIRRUS™ HD-OCT Model 6000 is OBO.

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Related Devices (Code: OBO)

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.

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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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