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FDA 510(k)

TNI softFlow 50

K-Number: K180474 · 2018-10-18

ApplicantTni Medical AG
Decision Date2018-10-18
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TNI softFlow 50 is a medical device manufactured by Tni Medical AG. It received FDA 510(k) clearance on 2018-10-18 under approval number K180474. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TNI softFlow 50?

TNI softFlow 50 is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Tni Medical AG. The 510(k) number is K180474.

When was TNI softFlow 50 approved by the FDA?

TNI softFlow 50 received FDA 510(k) clearance on 2018-10-18, under approval number K180474.

What company makes TNI softFlow 50?

TNI softFlow 50 is manufactured by Tni Medical AG.

What is the FDA product code for TNI softFlow 50?

The FDA product code for TNI softFlow 50 is BTT.

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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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