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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 the device name listed in this FDA 510(k) record. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. It received FDA 510(k) clearance on 2021-12-23 under 510(k) 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. The listed applicant is Meditera Tibbi Malzeme San VE Tic AS. The 510(k) number is K210992.

When did Altech® Exhalation Valve (Single Limb and Dual Limb) receive FDA 510(k) clearance?

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

Who is the listed applicant for Altech® Exhalation Valve (Single Limb and Dual Limb)?

The FDA 510(k) record lists Meditera Tibbi Malzeme San VE Tic AS as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Meditera Tibbi Malzeme San VE Tic AS as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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