Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)

About This 510(k) Submission

K243086 is an FDA 510(k) clearance for the Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91), a Oximeter (Class II — Special Controls, product code DQA), submitted by Unimed Medical Supplies, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on February 20, 2025, 143 days after receiving the submission on September 30, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.