Cleared Traditional

HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE

K992543 · Hewlett-Packard Co. · Cardiovascular

May 2000

Decision

293d

Days

Class 3

Risk

About This 510(k) Submission

K992543 is an FDA 510(k) clearance for the HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Hewlett-Packard Co. (Seattle, US). The FDA issued a Cleared decision on May 18, 2000, 293 days after receiving the submission on July 30, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K992543 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 1999
Decision Date	May 18, 2000
Days to Decision	293 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.