Cleared Traditional

K100654 - ZOLL PROPAQ MD
(FDA 510(k) Clearance)

K100654 · Zoll Medical Corporation, World Wide Headquarters · Cardiovascular

Jul 2010

Decision

143d

Days

Class 2

Risk

K100654 is an FDA 510(k) clearance for the ZOLL PROPAQ MD, a Dc-defibrillator, Low-energy, (including Paddles) (Class II — Special Controls, product code LDD), submitted by Zoll Medical Corporation, World Wide Headquarters (Chelmsford, US). The FDA issued a Cleared decision on July 29, 2010, 143 days after receiving the submission on March 8, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5300.

Submission Details

510(k) Number	K100654 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2010
Decision Date	July 29, 2010
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF