510(k) K234021

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 3, 2024

Date Received

December 20, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

870.2705

Review Panel

CV

Submission Type

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).