510(k) K260931

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) by Unimed Medical Supplies, Inc. — Product Code DQA

K260931 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)". The FDA issued a decision of Substantially Equivalent on April 14, 2026. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Unimed Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2026
Date Received
March 20, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type