T-PLUS
K-Number: K181893 · 2019-01-29
ApplicantWintecare SA
Decision Date2019-01-29
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
T-PLUS is a medical device manufactured by Wintecare SA. It received FDA 510(k) clearance on 2019-01-29 under approval number K181893. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the T-PLUS?
T-PLUS is a medical device that received FDA 510(k) clearance on 2019-01-29. It is manufactured by Wintecare SA. The 510(k) number is K181893.
When was T-PLUS approved by the FDA?
T-PLUS received FDA 510(k) clearance on 2019-01-29, under approval number K181893.
What company makes T-PLUS?
T-PLUS is manufactured by Wintecare SA.
What is the FDA product code for T-PLUS?
The FDA product code for T-PLUS is PBX.
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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.