700-FR Series Radiolucent Stimulation Electrodes

Q: What is the product code of K964991?

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

FDA 510(k) K964991 · Cardiotronics Systems, Inc.

Substantially Equivalent

510(k) numberK964991

Submission

Device name: 700-FR Series Radiolucent Stimulation Electrodes
Applicant: Cardiotronics Systems, Inc.
Carlsbad, CA, US
Received: December 13, 1996
Decision date: January 15, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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)	Device	Decision
K971148	700-SP Series Disposable Stimulation ElectrodesMKJ · Traditional	05/15/1997SE
K970719	700-MP Disposable Radiolucent Multi-Pad ElectrodesMKJ · Traditional	04/16/1997SE
K964469	700-F Series Stimulation ElectrodesLDD · Traditional	12/11/1996SE

Questions and answers

When was 700-FR Series Radiolucent Stimulation Electrodes cleared by the FDA?

700-FR Series Radiolucent Stimulation Electrodes (K964991) received a 510(k) decision of Substantially Equivalent on January 15, 1997, 33 days after the submission was received.

What is the product code of K964991?

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