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FDA 510(k)

ZEISS INFRARED 800 WITH FLOW 800 OPTION

K-Number: K100468 · 2010-03-03

ApplicantCarl Zeiss Surgical GmbH
Decision Date2010-03-03
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZEISS INFRARED 800 WITH FLOW 800 OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Surgical GmbH. It received FDA 510(k) clearance on 2010-03-03 under 510(k) number K100468. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZEISS INFRARED 800 WITH FLOW 800 OPTION?

ZEISS INFRARED 800 WITH FLOW 800 OPTION is a medical device that received FDA 510(k) clearance on 2010-03-03. The listed applicant is Carl Zeiss Surgical GmbH. The 510(k) number is K100468.

When did ZEISS INFRARED 800 WITH FLOW 800 OPTION receive FDA 510(k) clearance?

ZEISS INFRARED 800 WITH FLOW 800 OPTION received FDA 510(k) clearance on 2010-03-03, under 510(k) number K100468.

Who is the listed applicant for ZEISS INFRARED 800 WITH FLOW 800 OPTION?

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

What is the FDA product code for ZEISS INFRARED 800 WITH FLOW 800 OPTION?

The FDA product code for ZEISS INFRARED 800 WITH FLOW 800 OPTION is IZI.

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Other records listing Carl Zeiss Surgical GmbH as applicant

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Related Devices (Code: IZI)

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

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

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