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FDA 510(k)

LINE POWERED LOW ENERGY DEFIBRILLATOR II

K-Number: K813471 · 1981-12-29

ApplicantNarco Scientific
Decision Date1981-12-29
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LINE POWERED LOW ENERGY DEFIBRILLATOR II is the device name listed in this FDA 510(k) record. The listed applicant is Narco Scientific. It received FDA 510(k) clearance on 1981-12-29 under 510(k) number K813471. 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 LINE POWERED LOW ENERGY DEFIBRILLATOR II?

LINE POWERED LOW ENERGY DEFIBRILLATOR II is a medical device that received FDA 510(k) clearance on 1981-12-29. The listed applicant is Narco Scientific. The 510(k) number is K813471.

When did LINE POWERED LOW ENERGY DEFIBRILLATOR II receive FDA 510(k) clearance?

LINE POWERED LOW ENERGY DEFIBRILLATOR II received FDA 510(k) clearance on 1981-12-29, under 510(k) number K813471.

Who is the listed applicant for LINE POWERED LOW ENERGY DEFIBRILLATOR II?

The FDA 510(k) record lists Narco Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINE POWERED LOW ENERGY DEFIBRILLATOR II?

The FDA product code for LINE POWERED LOW ENERGY DEFIBRILLATOR II is LDD.

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Other records listing Narco Scientific as applicant

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K830338NARCOTRACE 80K831429AS 191 ECG TELEMETRY MODULEK831428AS 1740 INTERFACE MODULEK822835PZ-800 VOLUME VENTILATORK831430AIR SHIELDS AS-100 MONIORING SYS-AS105K831460AS 30/TCP MODULE

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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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