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FDA 510(k)

MEDEBAR XL

K-Number: K800844 · 1980-05-30

ApplicantMedefield Pty. , Ltd.
Decision Date1980-05-30
Product CodeKTA
DecisionSubstantially Equivalent

Device Summary

MEDEBAR XL is the device name listed in this FDA 510(k) record. The listed applicant is Medefield Pty. , Ltd.. It received FDA 510(k) clearance on 1980-05-30 under 510(k) number K800844. The device is classified under product code KTA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDEBAR XL?

MEDEBAR XL is a medical device that received FDA 510(k) clearance on 1980-05-30. The listed applicant is Medefield Pty. , Ltd.. The 510(k) number is K800844.

When did MEDEBAR XL receive FDA 510(k) clearance?

MEDEBAR XL received FDA 510(k) clearance on 1980-05-30, under 510(k) number K800844.

Who is the listed applicant for MEDEBAR XL?

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

What is the FDA product code for MEDEBAR XL?

The FDA product code for MEDEBAR XL is KTA.

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 Medefield Pty. , 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.

K800843MEDEFIZZ A & MEDEFIZZ BK800840MEDEFOAM-2K800839MEDESCANK800841MEDEBAR MK800842MEDEBAR XAC-90

Related Devices (Code: KTA)

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.

K800840MEDEFOAM-2Medefield Pty. , Ltd.K800843MEDEFIZZ A & MEDEFIZZ BMedefield Pty. , Ltd.K800839MEDESCANMedefield Pty. , Ltd.K800459BARIUM SULFATE, USP IN SUSPENSIONCentral Pharmaceuticals, Inc.K800841MEDEBAR MMedefield Pty. , Ltd.K800842MEDEBAR XAC-90Medefield Pty. , Ltd.

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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