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FDA 510(k)

CR 280/45, CR281/4 DEFIBRILLATOR

K-Number: K852905 · 1985-11-05

ApplicantCardiac Recorders, Ltd.
Decision Date1985-11-05
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CR 280/45, CR281/4 DEFIBRILLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Recorders, Ltd.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K852905. 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 CR 280/45, CR281/4 DEFIBRILLATOR?

CR 280/45, CR281/4 DEFIBRILLATOR is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Cardiac Recorders, Ltd.. The 510(k) number is K852905.

When did CR 280/45, CR281/4 DEFIBRILLATOR receive FDA 510(k) clearance?

CR 280/45, CR281/4 DEFIBRILLATOR received FDA 510(k) clearance on 1985-11-05, under 510(k) number K852905.

Who is the listed applicant for CR 280/45, CR281/4 DEFIBRILLATOR?

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

What is the FDA product code for CR 280/45, CR281/4 DEFIBRILLATOR?

The FDA product code for CR 280/45, CR281/4 DEFIBRILLATOR is LDD.

Related Clinical Trials

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.

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Other records listing Cardiac Recorders, Ltd. 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.

K864704CARDIAN III CR6AK861621CARDIAN II CR45AK853673CARDIORATER CR 51K852910CARDIORATER CR7K852887CR5 CARDIAC MONITORK8527992006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR)

View all 8 devices →

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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