K213948 is an FDA 510(k) clearance for the OxyMinder. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).
Submitted by Bio-Med Devices, Inc. (Guilford, US). The FDA issued a Cleared decision on March 17, 2022, 90 days after receiving the submission on December 17, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.
| 510(k) Number | K213948 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2021 |
| Decision Date | March 17, 2022 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCL — Analyzer, Gas, Oxygen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1720 |