# Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
> **Product code: QYU** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.2705
## Classification
- **FDA Product Code:** QYU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.2705
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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).

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QYU)
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