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FDA 510(k)

HEART SYNC PEDIATRIC PHYSIO AED PAD

K-Number: K120536 · 2012-08-06

ApplicantHeart Sync, Inc.
Decision Date2012-08-06
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART SYNC PEDIATRIC PHYSIO AED PAD 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 2012-08-06 under 510(k) number K120536. 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 PEDIATRIC PHYSIO AED PAD?

HEART SYNC PEDIATRIC PHYSIO AED PAD is a medical device that received FDA 510(k) clearance on 2012-08-06. The listed applicant is Heart Sync, Inc.. The 510(k) number is K120536.

When did HEART SYNC PEDIATRIC PHYSIO AED PAD receive FDA 510(k) clearance?

HEART SYNC PEDIATRIC PHYSIO AED PAD received FDA 510(k) clearance on 2012-08-06, under 510(k) number K120536.

Who is the listed applicant for HEART SYNC PEDIATRIC PHYSIO AED PAD?

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 PEDIATRIC PHYSIO AED PAD?

The FDA product code for HEART SYNC PEDIATRIC PHYSIO AED PAD 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.

K131550HEART SYNCK131494HEART SYNC

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.

K131550HEART SYNCHeart Sync, Inc.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 Systems

Official Source

View on FDA Database →

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

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