K241465 is an FDA 510(k) clearance for the Midas Flowmeter. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Parker Hannifin Corporation (Hatfield, US). The FDA issued a Cleared decision on September 19, 2024, 119 days after receiving the submission on May 23, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K241465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2024 |
| Decision Date | September 19, 2024 |
| Days to Decision | 119 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 |