Cleared Traditional

K002806 - K-DEFIB/PACE, MODEL KDP-60A
(FDA 510(k) Clearance)

K002806 · Katecho, Inc. · Cardiovascular

Nov 2000

Decision

74d

Days

Class 3

Risk

K002806 is an FDA 510(k) clearance for the K-DEFIB/PACE, MODEL KDP-60A, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Katecho, Inc. (Des Moines, US). The FDA issued a Cleared decision on November 21, 2000, 74 days after receiving the submission on September 8, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K002806 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2000
Decision Date	November 21, 2000
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

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.