510(k) K232512
K232512 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo W1". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Masimo Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2023
- Date Received
- August 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2340
- Review Panel
- CV
- Submission Type