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FDA 510(k)

TE ME NA POLYSTIM NERVE STIMILATOR

K-Number: K990323 · 2001-09-28

ApplicantTe ME NA S.A.R.L.
Decision Date2001-09-28
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TE ME NA POLYSTIM NERVE STIMILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Te ME NA S.A.R.L.. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K990323. 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 TE ME NA POLYSTIM NERVE STIMILATOR?

TE ME NA POLYSTIM NERVE STIMILATOR is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is Te ME NA S.A.R.L.. The 510(k) number is K990323.

When did TE ME NA POLYSTIM NERVE STIMILATOR receive FDA 510(k) clearance?

TE ME NA POLYSTIM NERVE STIMILATOR received FDA 510(k) clearance on 2001-09-28, under 510(k) number K990323.

Who is the listed applicant for TE ME NA POLYSTIM NERVE STIMILATOR?

The FDA 510(k) record lists Te ME NA S.A.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TE ME NA POLYSTIM NERVE STIMILATOR?

The FDA product code for TE ME NA POLYSTIM NERVE STIMILATOR 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 Te ME NA S.A.R.L. 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.

K002405SPINAL EPIDURAL NEEDLESK991259TE ME NA EPIDURAL CATHETERK990100POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLEK990020TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

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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