FDA 510(k)

HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST

K-Number: K130153 · 2013-03-12

Decision Date2013-03-12

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2013-03-12 under 510(k) number K130153. 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 HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST?

HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST is a medical device that received FDA 510(k) clearance on 2013-03-12. The listed applicant is Philips Medical Systems. The 510(k) number is K130153.

When did HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST receive FDA 510(k) clearance?

HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST received FDA 510(k) clearance on 2013-03-12, under 510(k) number K130153.

Who is the listed applicant for HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST?

The FDA product code for HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Philips Medical Systems as applicant

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System K210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph K191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph K192875Philips Biosensor BX100 K183387M3290B Patient Information Center iX

View all 99 devices →

Related Devices (Code: MKJ)

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems K131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K113787DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIESDefibtech, LLC

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.