Cleared Traditional

HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A

K991871 · Hewlett-Packard Co. · Cardiovascular

Aug 1999

Decision

65d

Days

Class 3

Risk

About This 510(k) Submission

K991871 is an FDA 510(k) clearance for the HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Hewlett-Packard Co. (Des Moines, US). The FDA issued a Cleared decision on August 5, 1999, 65 days after receiving the submission on June 1, 1999. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K991871 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1999
Decision Date	August 05, 1999
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

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.