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FDA 510(k)

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

K-Number: K182503 · 2019-06-03

ApplicantPhysio-Control, Inc.
Decision Date2019-06-03
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is a medical device manufactured by Physio-Control, Inc.. It received FDA 510(k) clearance on 2019-06-03 under approval number K182503. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is a medical device that received FDA 510(k) clearance on 2019-06-03. It is manufactured by Physio-Control, Inc.. The 510(k) number is K182503.

When was Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors approved by the FDA?

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors received FDA 510(k) clearance on 2019-06-03, under approval number K182503.

What company makes Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is manufactured by Physio-Control, Inc..

What is the FDA product code for Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

The FDA product code for Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors is LDD.

Related Clinical Trials

NCT07042061 Trial of Mobile External Defibrillator for Out-of-hospital Cardiac Arrest in Singapore. NOT_YET_RECRUITING

Other Devices by Physio-Control, Inc.

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) K253099LIFEPAK 15 AC Power Adapter (41577-000333) PMA P160012Automated external defibrillators (non-wearable) PMA P170018Automated external defibrillators (non-wearable) PMA P160026Automated external defibrillators (non-wearable)

Related Devices (Code: LDD)

K200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company K203231Switched Internal PaddlesPhilips North America, 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.

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