Pulse Oximeter For Over-The-Counter Use

FDA product code OLK · Class II (moderate risk) · 21 CFR 870.2700 · Cardiovascular

Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K211498Nonin OTC Pulse Oximeter Model 3250OLK · Traditional Nonin Medical, Inc.11/13/2024SE
K214115MightySat -OTCOLK · Traditional Masimo Corporation01/31/2024SE