Cleared Traditional

Altech? Exhalation Valve (Single Limb and Dual Limb)

K210992 · Meditera Tibbi Malzeme San VE Tic AS · Anesthesiology
Dec 2021
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K210992 is an FDA 510(k) clearance for the Altech? Exhalation Valve (Single Limb and Dual Limb), a Valve, Non-rebreathing (Class II — Special Controls, product code CBP), submitted by Meditera Tibbi Malzeme San VE Tic AS (Tire Izmir, TR). The FDA issued a Cleared decision on December 23, 2021, 265 days after receiving the submission on April 2, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5870.

Submission Details

510(k) Number K210992 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 2021
Decision Date December 23, 2021
Days to Decision 265 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBP — Valve, Non-rebreathing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5870

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