Cleared Special

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A

K003565 · Agilent Technologies, Inc. · Cardiovascular

Dec 2000

Decision

30d

Days

Class 3

Risk

About This 510(k) Submission

K003565 is an FDA 510(k) clearance for the HEARTSTREAM FR2 AED, MODEL M3860A,M3861A, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Agilent Technologies, Inc. (Seattle, US). The FDA issued a Cleared decision on December 20, 2000, 30 days after receiving the submission on November 20, 2000. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K003565 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2000
Decision Date	December 20, 2000
Days to Decision	30 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.