510(k) K140502

ZOLL E SERIES ALS by ZOLL Medical Corporation — Product Code LDD

K140502 is an FDA 510(k) premarket notification submitted by ZOLL Medical Corporation for the device "ZOLL E SERIES ALS". The FDA issued a decision of Substantially Equivalent on November 6, 2014. The device falls under product code LDD (Dc-Defibrillator, Low-Energy, (Including Paddles)), a Class II device regulated under 21 CFR 870.5300. ZOLL Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2014
Date Received
February 27, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dc-Defibrillator, Low-Energy, (Including Paddles)
Device Class
Class II
Regulation Number
870.5300
Review Panel
CV
Submission Type