K232354 is an FDA 510(k) clearance for the Vios Monitoring System(TM) Model 2050. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Murata Vios, Inc. (Woodbury, US). The FDA issued a Cleared decision on March 22, 2024, 228 days after receiving the submission on August 7, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K232354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2023 |
| Decision Date | March 22, 2024 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRT - Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |