- Device name
- Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2705
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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).