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FDA 510(k)

Idys-C ZP 3DTi

K-Number: K212562 · 2021-10-12

ApplicantClariance, SA
Decision Date2021-10-12
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Idys-C ZP 3DTi is a medical device manufactured by Clariance, SA. It received FDA 510(k) clearance on 2021-10-12 under approval number K212562. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Idys-C ZP 3DTi?

Idys-C ZP 3DTi is a medical device that received FDA 510(k) clearance on 2021-10-12. It is manufactured by Clariance, SA. The 510(k) number is K212562.

When was Idys-C ZP 3DTi approved by the FDA?

Idys-C ZP 3DTi received FDA 510(k) clearance on 2021-10-12, under approval number K212562.

What company makes Idys-C ZP 3DTi?

Idys-C ZP 3DTi is manufactured by Clariance, SA.

What is the FDA product code for Idys-C ZP 3DTi?

The FDA product code for Idys-C ZP 3DTi is OVE.

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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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