K202480 is an FDA 510(k) clearance for the Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Parker Hannifin (Hatfield, US). The FDA issued a Cleared decision on April 22, 2021, 237 days after receiving the submission on August 28, 2020.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K202480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2020 |
| Decision Date | April 22, 2021 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZR - Mixer, Breathing Gases, Anesthesia Inhalation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5330 |