Cleared Traditional

HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B

K010634 · Agilent Technologies, Inc. · Cardiovascular

Jun 2001

Decision

101d

Days

Class 3

Risk

About This 510(k) Submission

K010634 is an FDA 510(k) clearance for the HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Agilent Technologies, Inc. (Andover, US). The FDA issued a Cleared decision on June 11, 2001, 101 days after receiving the submission on March 2, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K010634 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2001
Decision Date	June 11, 2001
Days to Decision	101 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.