TCD-X
K-Number: K182175 · 2019-04-05
ApplicantAtys
Decision Date2019-04-05
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TCD-X is the device name listed in this FDA 510(k) record. The listed applicant is Atys. It received FDA 510(k) clearance on 2019-04-05 under 510(k) 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. The listed applicant is Atys. The 510(k) number is K182175.
When did TCD-X receive FDA 510(k) clearance?
TCD-X received FDA 510(k) clearance on 2019-04-05, under 510(k) number K182175.
Who is the listed applicant for TCD-X?
The FDA 510(k) record lists Atys as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TCD-X?
The FDA product code for TCD-X is IYN.
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Official Source
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