FDA 510(k)

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR

K-Number: K130454 · 2013-08-21

Decision Date2013-08-21

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control, Inc.. It received FDA 510(k) clearance on 2013-08-21 under 510(k) number K130454. 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 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR?

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR is a medical device that received FDA 510(k) clearance on 2013-08-21. The listed applicant is Physio-Control, Inc.. The 510(k) number is K130454.

When did LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR receive FDA 510(k) clearance?

LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR received FDA 510(k) clearance on 2013-08-21, under 510(k) number K130454.

Who is the listed applicant for LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR?

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

What is the FDA product code for LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR?

The FDA product code for LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR is MKJ. This falls under the Dental category.

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Other records listing Physio-Control, Inc. as applicant

K253099LIFEPAK 15 AC Power Adapter (41577-000333)K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)K182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors K123597TRUECPR COACHING DEVICE K122600LIFEPAK 1000 DEFIBRILLATOR K103567LIFEPAK 15 MONITOR/DEFIBRILLATOR

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Related Devices (Code: MKJ)

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical Systems K131494HEART SYNCHeart Sync, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems 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.