510(k) K142489

Unimed Disposable ECG lead wires by Unimed Medical Supplies, Inc. — Product Code DSA

K142489 is an FDA 510(k) premarket notification submitted by Unimed Medical Supplies, Inc. for the device "Unimed Disposable ECG lead wires". The FDA issued a decision of Substantially Equivalent on November 4, 2014. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. Unimed Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2014
Date Received
September 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type