FDA 510(k)

Altech® Exhalation Valve (Single Limb and Dual Limb)

K-번호: K210992 · 2021-12-23

결정일2021-12-23

제품 코드CBP

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Meditera Tibbi Malzeme San VE Tic AS를 신청인으로 등재한 기타 기록

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