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)

PAIRED HYDROGEL ELECTRODE

K-Number: K110138 · 2011-04-08

ApplicantNeurovision Medical Products, Inc.
Decision Date2011-04-08
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PAIRED HYDROGEL ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Neurovision Medical Products, Inc.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K110138. The device is classified under product code ETN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAIRED HYDROGEL ELECTRODE?

PAIRED HYDROGEL ELECTRODE is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Neurovision Medical Products, Inc.. The 510(k) number is K110138.

When did PAIRED HYDROGEL ELECTRODE receive FDA 510(k) clearance?

PAIRED HYDROGEL ELECTRODE received FDA 510(k) clearance on 2011-04-08, under 510(k) number K110138.

Who is the listed applicant for PAIRED HYDROGEL ELECTRODE?

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

What is the FDA product code for PAIRED HYDROGEL ELECTRODE?

The FDA product code for PAIRED HYDROGEL ELECTRODE is ETN.

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 Neurovision Medical Products, 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.

K130570NEUROVISION MEDICAL MOTION SENSORK130806NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEK113771SIGNAL GEAR URETHRAL CATHETER ELECTRODEK121931NONDISPOSABLE STIMULATING INSTRUMENTSK110989NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEK110140NEUROVISION NERVE LOCATOR MONITOR

View all 9 devices →

Related Devices (Code: ETN)

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.

K253536Evala Nerve Stimulator (EPNR002)Epineuron Technologies, Inc.K251672NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotracheal Tube (NIMEID070); NIM Essence™ EMG Endotracheal Tube (NIMEID075); NIM Essence™ EMG Endotracheal Tube (NIMEID080)Medtronic Xomed, Inc.K242852ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847)Inomed Medizintechnik GmbHK233001Bioscope Neuromonitor DeviceBiosys Biyomedikal Muhendislik San. VE Tic. A.S.K241917EARP Nerve Cuff ElectrodeRetropsoas Technologies, LLCK232888Disposable Laryngeal ElectrodesSuzhou Haishen Medical Device Associates Co., 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.

↑