FDA 510(k)

LIFEPAK 15 MONITOR/DEFIBRILLATOR

K-Number: K082937 · 2009-03-11

Decision Date2009-03-11

Product CodeMKJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

LIFEPAK 15 MONITOR/DEFIBRILLATOR 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 2009-03-11 under 510(k) number K082937. 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 15 MONITOR/DEFIBRILLATOR?

LIFEPAK 15 MONITOR/DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 2009-03-11. The listed applicant is Physio-Control, Inc.. The 510(k) number is K082937.

When did LIFEPAK 15 MONITOR/DEFIBRILLATOR receive FDA 510(k) clearance?

LIFEPAK 15 MONITOR/DEFIBRILLATOR received FDA 510(k) clearance on 2009-03-11, under 510(k) number K082937.

Who is the listed applicant for LIFEPAK 15 MONITOR/DEFIBRILLATOR?

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 15 MONITOR/DEFIBRILLATOR?

The FDA product code for LIFEPAK 15 MONITOR/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_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 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 K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR K123597TRUECPR COACHING DEVICE K122600LIFEPAK 1000 DEFIBRILLATOR

View all 13 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.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.