K223452 is an FDA 510(k) clearance for the Nitronox Scavenger Plus. This device is classified as a Apparatus, Gas-scavenging (Class II - Special Controls, product code CBN).
Submitted by Parker Hannifin Corporation (Hatfield, US). The FDA issued a Cleared decision on March 5, 2023, 110 days after receiving the submission on November 15, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5430.
| 510(k) Number | K223452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2022 |
| Decision Date | March 05, 2023 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| 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 |