QYU — Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use Class II
FDA product code QYU covers "Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use", a Class II medical device regulated under 21 CFR 870.2705. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QYU
- Device Class
- Class II
- Regulation Number
- 870.2705
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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).