K240229 is an FDA 510(k) clearance for the Masimo W1. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on August 8, 2024, 192 days after receiving the submission on January 29, 2024.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K240229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2024 |
| Decision Date | August 08, 2024 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |