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FDA 510(k)

ZIT-Z

K-Number: K092507 · 2010-05-11

ApplicantZiterion
Decision Date2010-05-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIT-Z is the device name listed in this FDA 510(k) record. The listed applicant is Ziterion. It received FDA 510(k) clearance on 2010-05-11 under 510(k) number K092507. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIT-Z?

ZIT-Z is a medical device that received FDA 510(k) clearance on 2010-05-11. The listed applicant is Ziterion. The 510(k) number is K092507.

When did ZIT-Z receive FDA 510(k) clearance?

ZIT-Z received FDA 510(k) clearance on 2010-05-11, under 510(k) number K092507.

Who is the listed applicant for ZIT-Z?

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

What is the FDA product code for ZIT-Z?

The FDA product code for ZIT-Z is DZE.

Related Devices (Code: DZE)

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.

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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