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FDA 510(k)

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)

K-Number: K052161 · 2005-10-21

ApplicantCardiac Science, Inc.
Decision Date2005-10-21
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Science, Inc.. It received FDA 510(k) clearance on 2005-10-21 under 510(k) number K052161. 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 POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)?

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) is a medical device that received FDA 510(k) clearance on 2005-10-21. The listed applicant is Cardiac Science, Inc.. The 510(k) number is K052161.

When did POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) receive FDA 510(k) clearance?

POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) received FDA 510(k) clearance on 2005-10-21, under 510(k) number K052161.

Who is the listed applicant for POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)?

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

What is the FDA product code for POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)?

The FDA product code for POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A) is MKJ. This falls under the Dental category.

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Other records listing Cardiac Science, Inc. as applicant

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.

K052316POWERHEART ECDK040637POWERHEART AED G3 PROK040438POWERHEART AED G3AK022929PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210K022210MULTIFUNCTIONAL ELECTRODE MODELS 9640, 9650K012197POWERHEART CARDIAC RHYTHM MODULE

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Related Devices (Code: MKJ)

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.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART 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.

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