Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
The infant pulse rate and oxygen saturation monitor for over-the-counter use (product code QYU) is a Class 2 Cardiovascular device (regulation 870.2705) that uses photoplethysmography to measure pulse rate and oxygen saturation in infants, and may include alarms to alert caregivers when vital signs fall outside preset thresholds. Requiring 510(k) clearance, it is designed for consumer use. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QYU
- Device Class
- FDA class 2
- Regulation Number
- 870.2705
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.