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FDA 510(k)

DEFIGARD 2000

K-Number: K854175 · 1986-01-13

ApplicantOdam
Decision Date1986-01-13
Product CodeLDD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEFIGARD 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Odam. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K854175. 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 DEFIGARD 2000?

DEFIGARD 2000 is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Odam. The 510(k) number is K854175.

When did DEFIGARD 2000 receive FDA 510(k) clearance?

DEFIGARD 2000 received FDA 510(k) clearance on 1986-01-13, under 510(k) number K854175.

Who is the listed applicant for DEFIGARD 2000?

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

What is the FDA product code for DEFIGARD 2000?

The FDA product code for DEFIGARD 2000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Odam 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.

K972535MAGLIFE CK950264MAGLIFEK823934CARIEL F12K823931DEFIGARD M(OR DEFISCOPE MK823933MINIDEF (OR DEFIPORT

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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