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FDA 510(k)

TCD-X

K-Number: K182175 · 2019-04-05

ApplicantAtys
Decision Date2019-04-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCD-X is a medical device manufactured by Atys. It received FDA 510(k) clearance on 2019-04-05 under approval number K182175. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCD-X?

TCD-X is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Atys. The 510(k) number is K182175.

When was TCD-X approved by the FDA?

TCD-X received FDA 510(k) clearance on 2019-04-05, under approval number K182175.

What company makes TCD-X?

TCD-X is manufactured by Atys.

What is the FDA product code for TCD-X?

The FDA product code for TCD-X is IYN.

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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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