Heart Sync

FDA 510(k) K131550 · Heart Sync, Inc.

Substantially Equivalent

510(k) numberK131550

Submission

Device name
Heart Sync
Applicant
Heart Sync, Inc.
Naples, FL, US
Received
May 29, 2013
Decision date
December 6, 2013
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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K142709samaritan PAD 450PMKJ · Traditional Heartsine Technologies, Inc.03/27/2015SE
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K133239Zoll E SeriesMKJ · Traditional Zoll Medical Corporation, World Wide Headquarters01/16/2015SE
K142430LIFEPAK 15 monitor/defibrillatorMKJ · Traditional Physio-Control, Inc.12/19/2014SE
K141795Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional R & D Batteries, Inc.12/08/2014SE
K142915ZOLL X SeriesMKJ · Traditional ZOLL Medical Corporation12/03/2014SE
K142803Skintact, various other tradenamesMKJ · Traditional Leonhard Lang GmbH12/02/2014SE

More from Leonhard Lang GmbH

510(k)DeviceDecision
K131494Heart SyncMKJ · Traditional 09/16/2013SE
K120536Heart Sync Pediatric Physio AED PadMKJ · Traditional 08/06/2012SE
K081442Heart Sync Pediatric, Model PED-100LDD · Traditional 09/24/2008SE
K080421Heart Sync, Models C-100 and T-100MKJ · Traditional 02/29/2008SE

Questions and answers

When was Heart Sync cleared by the FDA?

Heart Sync (K131550) received a 510(k) decision of Substantially Equivalent on December 6, 2013, 191 days after the submission was received.

What is the product code of K131550?

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