Padpro, Model 2502

FDA 510(k) K020743 · Padpro, LLC

Substantially Equivalent

510(k) numberK020743

Submission

Device name
Padpro, Model 2502
Applicant
Padpro, LLC
Deer Field, IL, US
Received
March 6, 2002
Decision date
May 28, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MKJ – Automated External Defibrillators (Non-Wearable)
Device class
Class III (high risk)
Regulation
21 CFR 870.5310
Specialty
Cardiovascular

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…

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More from Leonhard Lang GmbH

510(k)DeviceDecision
K020203Padpro Model #2516MKJ · Special 05/08/2002SE
K020288Padpro, Model 2603MKJ · Special 02/27/2002SE
K014209Padpro Model 2001, 2001-S, 2001-C, 2001-EPSMKJ · Special 01/18/2002SE
K003548Padpro System Defibrillator Electrode AdaptersMKJ · Traditional 09/04/2001SE

Questions and answers

When was Padpro, Model 2502 cleared by the FDA?

Padpro, Model 2502 (K020743) received a 510(k) decision of Substantially Equivalent on May 28, 2002, 83 days after the submission was received.

What is the product code of K020743?

The FDA product code is MKJ – Automated External Defibrillators (Non-Wearable), a Class III (high risk) device regulated under 21 CFR 870.5310.