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FDA 510(k)

LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM

K-Number: K010918 · 2001-08-23

ApplicantMedtronic Physio-Control Corp.
Decision Date2001-08-23
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Physio-Control Corp.. It received FDA 510(k) clearance on 2001-08-23 under 510(k) number K010918. 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 - Subject to Tracking Reg..

Frequently Asked Questions

What is the LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM?

LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-23. The listed applicant is Medtronic Physio-Control Corp.. The 510(k) number is K010918.

When did LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM receive FDA 510(k) clearance?

LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM received FDA 510(k) clearance on 2001-08-23, under 510(k) number K010918.

Who is the listed applicant for LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM?

The FDA 510(k) record lists Medtronic Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM?

The FDA product code for LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM is MKJ. This falls under the Dental category.

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Other records listing Medtronic Physio-Control Corp. 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.

K040775LIFEPAK 12K033275LIFEPAK 12, 20, 500, CR PLUSK022732INFANT/CHILD REDUCED ENERGY ELECTRODESK012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKERK011144LIFEPAK 600 AUTOMATED EXTERNAL DEFIBRILLATORK012428MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR

View all 8 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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