Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wintecare SA. It received FDA 510(k) clearance on 2019-01-29 under 510(k) 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. The listed applicant is Wintecare SA. The 510(k) number is K181893.

When did T-PLUS receive FDA 510(k) clearance?

T-PLUS received FDA 510(k) clearance on 2019-01-29, under 510(k) number K181893.

Who is the listed applicant for T-PLUS?

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

What is the FDA product code for T-PLUS?

The FDA product code for T-PLUS is PBX.

Related Devices (Code: PBX)

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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.

↑