K193646 is an FDA 510(k) clearance for the Dynamic Gas Scavenging System 2 (DGSS - 2). This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).
Submitted by Anesthetic Gas Reclamation, Inc. (Dallas, US). The FDA issued a Cleared decision on December 4, 2020, 340 days after receiving the submission on December 30, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.
| 510(k) Number | K193646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2019 |
| Decision Date | December 04, 2020 |
| Days to Decision | 340 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBN - Apparatus, Gas-scavenging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5430 |