FDA 510(k)

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors

K-Nummer: K182503 · 2019-06-03

Entscheidungsdatum2019-06-03

ProduktcodeLDD

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors 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 2019-06-03 under 510(k) number K182503. The device is classified under product code LDD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

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. The listed applicant is Physio-Control, Inc.. The 510(k) number is K182503.

When did Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors receive FDA 510(k) clearance?

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

Who is the listed applicant for Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors?

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 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.

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Weitere Einträge mit Physio-Control, Inc. als Antragsteller

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)

Verwandte Geräte (Code: LDD)

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

Offizielle Quelle

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