Cleared Traditional

HEARTSINE SAMARITAN PAD 350P

K123881 · Heartsine Technologies, Inc. · Cardiovascular

Jul 2013

Decision

206d

Days

Class 3

Risk

About This 510(k) Submission

K123881 is an FDA 510(k) clearance for the HEARTSINE SAMARITAN PAD 350P, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Heartsine Technologies, Inc. (Northern, IE). The FDA issued a Cleared decision on July 11, 2013, 206 days after receiving the submission on December 17, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K123881 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2012
Decision Date	July 11, 2013
Days to Decision	206 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.