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FDA 510(k)

CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)

K-Number: K852808 · 1985-09-16

ApplicantCardiac Recorders, Ltd.
Decision Date1985-09-16
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) 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 1985-09-16 under 510(k) number K852808. 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 CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)?

CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Cardiac Recorders, Ltd.. The 510(k) number is K852808.

When did CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) receive FDA 510(k) clearance?

CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) received FDA 510(k) clearance on 1985-09-16, under 510(k) number K852808.

Who is the listed applicant for CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)?

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 CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO)?

The FDA product code for CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) is LDD.

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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 MONITORK852905CR 280/45, CR281/4 DEFIBRILLATOR

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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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