Identifiers
- 510(k) Number
- K240229 FDA 510(k)
- FDA Product Code
- DPS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2340 FDA 510(k)
- Regulation Number
- 870.2340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Masimo W1 is a medical device designed for cardiovascular monitoring. It functions to track physiological data to assist in clinical assessment.
This device is authorized via FDA 510k clearance under the traditional pathway. It is identified by the product code DPS and is manufactured by Masimo Corporation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Masimo - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240229 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) K240229 24 fields · synced Sep 24, 2026