Cleared Special

HEARTSINE SAMARITAN PAD

K041067 · Heartsine Technologies, Inc. · Cardiovascular

May 2004

Decision

32d

Days

Class 3

Risk

About This 510(k) Submission

K041067 is an FDA 510(k) clearance for the HEARTSINE SAMARITAN PAD, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Heartsine Technologies, Inc. (San Clemente, US). The FDA issued a Cleared decision on May 25, 2004, 32 days after receiving the submission on April 23, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K041067 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2004
Decision Date	May 25, 2004
Days to Decision	32 days
Submission Type	Special
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.