Cleared Traditional

DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325

K100565 · Bio-Detek, Inc. · Cardiovascular

Nov 2010

Decision

260d

Days

Class 3

Risk

About This 510(k) Submission

K100565 is an FDA 510(k) clearance for the DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Bio-Detek, Inc. (Pawtucket, US). The FDA issued a Cleared decision on November 16, 2010, 260 days after receiving the submission on March 1, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K100565 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2010
Decision Date	November 16, 2010
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MKJ — Automated External Defibrillators (non-wearable)
Device Class	Class III — Premarket Approval
CFR Regulation	21 CFR 870.5310
Definition	This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.