K233038 is an FDA 510(k) clearance for the Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on March 8, 2024, 165 days after receiving the submission on September 25, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K233038 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2023 |
| Decision Date | March 08, 2024 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |