Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use
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).