510(k) K070926

ELECTRODE/EXTENSION CABLES, MODELS ATAR by Oscor, Inc. — Product Code IKD

K070926 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "ELECTRODE/EXTENSION CABLES, MODELS ATAR". The FDA issued a decision of Substantially Equivalent on June 7, 2007. The device falls under product code IKD (Cable, Electrode), a Class II device regulated under 21 CFR 890.1175. Oscor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2007
Date Received
April 3, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Electrode
Device Class
Class II
Regulation Number
890.1175
Review Panel
PM
Submission Type