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FDA 510(k)

HEARTSTART MRX MONITOR/DEFIBRILLATOR

K-Number: K062233 · 2006-11-22

ApplicantPhilips Medical Systems North America, Inc.
Decision Date2006-11-22
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTSTART MRX MONITOR/DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 2006-11-22 under 510(k) number K062233. 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 HEARTSTART MRX MONITOR/DEFIBRILLATOR?

HEARTSTART MRX MONITOR/DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2006-11-22. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K062233.

When did HEARTSTART MRX MONITOR/DEFIBRILLATOR receive FDA 510(k) clearance?

HEARTSTART MRX MONITOR/DEFIBRILLATOR received FDA 510(k) clearance on 2006-11-22, under 510(k) number K062233.

Who is the listed applicant for HEARTSTART MRX MONITOR/DEFIBRILLATOR?

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

What is the FDA product code for HEARTSTART MRX MONITOR/DEFIBRILLATOR?

The FDA product code for HEARTSTART MRX MONITOR/DEFIBRILLATOR is MKJ. This falls under the Dental category.

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Other records listing Philips Medical Systems North America, 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.

K102005ALLURA XPER OR TABLE SERIESK062283THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORSK061052THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90K050151MULTIDIAGNOST ELEVAK042867PHILIPS ORTHOPAEDIC APPLICATIONSK041602PANORAMA 1.0T

View all 71 devices →

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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