Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

K-Number: K052057 · 2006-02-17

ApplicantMedtronic Emergency Response Systems, Inc.
Decision Date2006-02-17
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Emergency Response Systems, Inc.. It received FDA 510(k) clearance on 2006-02-17 under 510(k) number K052057. 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 LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR?

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2006-02-17. The listed applicant is Medtronic Emergency Response Systems, Inc.. The 510(k) number is K052057.

When did LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR receive FDA 510(k) clearance?

LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR received FDA 510(k) clearance on 2006-02-17, under 510(k) number K052057.

Who is the listed applicant for LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR?

The FDA 510(k) record lists Medtronic Emergency Response Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR?

The FDA product code for LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR 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 Medtronic Emergency Response Systems, 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.

K063510LIFEPAK 12 DEFIBRILLATOR/MONITORK063119LIFEPAK 20 DEFIBRILLATOR/ MONITORK052854LIFENET EXCHANGE SYSTEMK042404LIFEPAK, MODEL 1000K041459LIFEPAK 12 DEFIBRILLATOR/MONITOR

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.

↑