K210992 is an FDA 510(k) clearance for the Altech® Exhalation Valve (Single Limb and Dual Limb). This device is classified as 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 FDA review panel. Regulated under 21 CFR 868.5870.
| 510(k) Number | K210992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | CBP - Valve, Non-rebreathing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5870 |