Device |
infant pulse rate and oxygen saturation monitor for over-the-counter use |
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). |
Product Code | QYU |
Regulation Number |
870.2705
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Device Class |
2
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