Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NEUROSTIM II

K-Number: K822138 · 1982-07-30

ApplicantNeuro Technology
Decision Date1982-07-30
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NEUROSTIM II is the device name listed in this FDA 510(k) record. The listed applicant is Neuro Technology. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K822138. 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 NEUROSTIM II?

NEUROSTIM II is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Neuro Technology. The 510(k) number is K822138.

When did NEUROSTIM II receive FDA 510(k) clearance?

NEUROSTIM II received FDA 510(k) clearance on 1982-07-30, under 510(k) number K822138.

Who is the listed applicant for NEUROSTIM II?

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

What is the FDA product code for NEUROSTIM II?

The FDA product code for NEUROSTIM II 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 Neuro Technology 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.

K925014E-SP COMBINED EPI SPINAL MINISETK901810MICRO-SP LUMBAR PUNCTURE (SPINAL) NEEDLEK901811ADD'L DATA E-SP MULTIPURPOSE EPIDURAL SPINALNEEDLEK822139STIMPEN

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

View on FDA Database →

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

↑