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FDA 510(k)

MYOGRAPH 2000

K-Number: K830058 · 1983-03-07

ApplicantProthia USA, Inc.
Decision Date1983-03-07
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MYOGRAPH 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Prothia USA, Inc.. It received FDA 510(k) clearance on 1983-03-07 under 510(k) number K830058. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYOGRAPH 2000?

MYOGRAPH 2000 is a medical device that received FDA 510(k) clearance on 1983-03-07. The listed applicant is Prothia USA, Inc.. The 510(k) number is K830058.

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

MYOGRAPH 2000 received FDA 510(k) clearance on 1983-03-07, under 510(k) number K830058.

Who is the listed applicant for MYOGRAPH 2000?

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

What is the FDA product code for MYOGRAPH 2000?

The FDA product code for MYOGRAPH 2000 is BXN.

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 Prothia USA, Inc. 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.

K831071UNIVERSAL INSTRU. SET FOR NEUROVASCULARK830993AMPLIGREFFEK823581ELPHA 500K823583MYOTEST NERVE STIMULATOR

Related Devices (Code: BXN)

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.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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