Cleared Traditional

HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR

K982025 · Hewlett-Packard Co. · Cardiovascular

Sep 1998

Decision

87d

Days

Class 3

Risk

About This 510(k) Submission

K982025 is an FDA 510(k) clearance for the HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on September 4, 1998, 87 days after receiving the submission on June 9, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K982025 FDA.gov
FDA Decision	Cleared ST
Date Received	June 09, 1998
Decision Date	September 04, 1998
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—

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.