K222794 is an FDA 510(k) clearance for the FlowStar Touch Digital Mixer Flowmeter. This device is classified as a Mixer, Breathing Gases, Anesthesia Inhalation (Class II - Special Controls, product code BZR).
Submitted by Baldus Sedation GmbH & Co. KG (Bendorf, DE). The FDA issued a Cleared decision on July 28, 2023, 315 days after receiving the submission on September 16, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5330.
| 510(k) Number | K222794 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2022 |
| Decision Date | July 28, 2023 |
| Days to Decision | 315 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 |