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FDA 510(k)

Altech® Exhalation Valve (Single Limb and Dual Limb)

K-Number: K210992 · 2021-12-23

ApplicantMeditera Tibbi Malzeme San VE Tic AS
Decision Date2021-12-23
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Altech® Exhalation Valve (Single Limb and Dual Limb) is a medical device manufactured by Meditera Tibbi Malzeme San VE Tic AS. It received FDA 510(k) clearance on 2021-12-23 under approval number K210992. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altech® Exhalation Valve (Single Limb and Dual Limb)?

Altech® Exhalation Valve (Single Limb and Dual Limb) is a medical device that received FDA 510(k) clearance on 2021-12-23. It is manufactured by Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K210992.

When was Altech® Exhalation Valve (Single Limb and Dual Limb) approved by the FDA?

Altech® Exhalation Valve (Single Limb and Dual Limb) received FDA 510(k) clearance on 2021-12-23, under approval number K210992.

What company makes Altech® Exhalation Valve (Single Limb and Dual Limb)?

Altech® Exhalation Valve (Single Limb and Dual Limb) is manufactured by Meditera Tibbi Malzeme San VE Tic AS.

What is the FDA product code for Altech® Exhalation Valve (Single Limb and Dual Limb)?

The FDA product code for Altech® Exhalation Valve (Single Limb and Dual Limb) is CBP.

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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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