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FDA 510(k)

TRUECPR COACHING DEVICE

K-Number: K123597 · 2013-04-17

ApplicantPhysio-Control, Inc.
Decision Date2013-04-17
Product CodeLIX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUECPR COACHING DEVICE 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 2013-04-17 under 510(k) number K123597. The device is classified under product code LIX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUECPR COACHING DEVICE?

TRUECPR COACHING DEVICE is a medical device that received FDA 510(k) clearance on 2013-04-17. The listed applicant is Physio-Control, Inc.. The 510(k) number is K123597.

When did TRUECPR COACHING DEVICE receive FDA 510(k) clearance?

TRUECPR COACHING DEVICE received FDA 510(k) clearance on 2013-04-17, under 510(k) number K123597.

Who is the listed applicant for TRUECPR COACHING DEVICE?

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 TRUECPR COACHING DEVICE?

The FDA product code for TRUECPR COACHING DEVICE is LIX.

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Other records listing Physio-Control, Inc. as applicant

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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/monitorsK130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORK122600LIFEPAK 1000 DEFIBRILLATORK103567LIFEPAK 15 MONITOR/DEFIBRILLATOR

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Related Devices (Code: LIX)

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.

K201581CPR BANDCredoK183348Reusable Silicone Cover CPRmeter 2Laerdal Medical ASK173886CPRmeter 2 CPR Feedback DeviceLaerdal Medical ASK123248CPR RSQ ASSISTAvantech, Inc.K122050CPRMETER CPR FEEDBACK DEVICELaerdal Medical A/SK112660POCKETCPRZoll Medical Corp

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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