Cleared Traditional

SAMARITAN AED, MODEL SAM-01

K023854 · Heartsine Technologies, Inc. · Cardiovascular

Feb 2003

Decision

87d

Days

Class 3

Risk

About This 510(k) Submission

K023854 is an FDA 510(k) clearance for the SAMARITAN AED, MODEL SAM-01, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Heartsine Technologies, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on February 14, 2003, 87 days after receiving the submission on November 19, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K023854 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 19, 2002
Decision Date	February 14, 2003
Days to Decision	87 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.