510(k) K142832

Unimed Disposable and Reusable SPO2 Sensors by Unimed Medical Supplies, Inc. — Product Code DQA

K142832 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Unimed Disposable and Reusable SPO2 Sensors". The FDA issued a decision of Substantially Equivalent on February 6, 2015. 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
February 6, 2015
Date Received
September 30, 2014
Clearance Type
Traditional
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