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FDA 510(k)

HEART SYNC

K-Number: K131550 · 2013-12-06

ApplicantHeart Sync, Inc.
Decision Date2013-12-06
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART SYNC is the device name listed in this FDA 510(k) record. The listed applicant is Heart Sync, Inc.. It received FDA 510(k) clearance on 2013-12-06 under 510(k) number K131550. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART SYNC?

HEART SYNC is a medical device that received FDA 510(k) clearance on 2013-12-06. The listed applicant is Heart Sync, Inc.. The 510(k) number is K131550.

When did HEART SYNC receive FDA 510(k) clearance?

HEART SYNC received FDA 510(k) clearance on 2013-12-06, under 510(k) number K131550.

Who is the listed applicant for HEART SYNC?

The FDA 510(k) record lists Heart Sync, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEART SYNC?

The FDA product code for HEART SYNC is MKJ. This falls under the Dental category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Heart Sync, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131494HEART SYNCK120536HEART SYNC PEDIATRIC PHYSIO AED PAD

Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical SystemsK113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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