K223818 is an FDA 510(k) clearance for the Model 9160 VitaloQUB. This device is classified as a Plethysmograph, Volume (Class II - Special Controls, product code JEH).
Submitted by Vitalograph (Ireland) , Ltd. (Ennis Co Clare, IE). The FDA issued a Cleared decision on May 25, 2023, 155 days after receiving the submission on December 21, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1760.
| 510(k) Number | K223818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2022 |
| Decision Date | May 25, 2023 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | JEH - Plethysmograph, Volume |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1760 |