Cleared Traditional

ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX

K984582 · Bio-Detek, Inc. · Cardiovascular

Mar 1999

Decision

83d

Days

Class 3

Risk

About This 510(k) Submission

K984582 is an FDA 510(k) clearance for the ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX, a Automated External Defibrillators (non-wearable) (Class III — Premarket Approval, product code MKJ), submitted by Bio-Detek, Inc. (Pawtucket, US). The FDA issued a Cleared decision on March 16, 1999, 83 days after receiving the submission on December 23, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5310.

Submission Details

510(k) Number	K984582 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1998
Decision Date	March 16, 1999
Days to Decision	83 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.