510(k) K234021
K234021 is an FDA 510(k) premarket notification submitted by Masimo Corporation for the device "Masimo Stork". The FDA issued a decision of Substantially Equivalent on May 3, 2024. The device falls under product code QYU (Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use), a Class II device regulated under 21 CFR 870.2705. Masimo Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 2024
- Date Received
- December 20, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Device Class
- Class II
- Regulation Number
- 870.2705
- Review Panel
- CV
- Submission Type
An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).