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FDA 510(k)

LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)

K-Number: K895379 · 1990-02-26

ApplicantPhysio-Control Corp.
Decision Date1990-02-26
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) is the device name listed in this FDA 510(k) record. The listed applicant is Physio-Control Corp.. It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K895379. 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 LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)?

LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Physio-Control Corp.. The 510(k) number is K895379.

When did LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) receive FDA 510(k) clearance?

LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) received FDA 510(k) clearance on 1990-02-26, under 510(k) number K895379.

Who is the listed applicant for LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)?

The FDA 510(k) record lists Physio-Control Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)?

The FDA product code for LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES) is LDD.

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Other records listing Physio-Control Corp. 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.

K991910LIFEPAK 12 BIPHASICK990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMK983393LIFEPAK 500 BIPHASICK973486LIFE PAK 12K962359LIFEPAK 300K955854LIFEPAK 500

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Related Devices (Code: LDD)

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.

K203231Switched Internal PaddlesPhilips North America, LLCK200849Tempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips CompanyK182503Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitorsPhysio-Control, Inc.K103651CARDIOMEDCardio Medical Products, Inc.K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRICFiab SpaK103334CARDIO MEDCardio Medical Products, Inc.

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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