K223217 is an FDA 510(k) clearance for the Zynex Monitoring System, Model CM-1600. This device is classified as a Plethysmograph, Impedance (Class II - Special Controls, product code DSB).
Submitted by Zynex Medical, Inc. (Englewood, US). The FDA issued a Cleared decision on June 16, 2023, 242 days after receiving the submission on October 17, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2770.
| 510(k) Number | K223217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2022 |
| Decision Date | June 16, 2023 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSB - Plethysmograph, Impedance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2770 |