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)

HILGER DUAL-STIM NERVE STIMULATOR

K-Number: K063560 · 2007-01-05

ApplicantWr Medical Electronics Co.
Decision Date2007-01-05
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HILGER DUAL-STIM NERVE STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Wr Medical Electronics Co.. It received FDA 510(k) clearance on 2007-01-05 under 510(k) number K063560. 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 HILGER DUAL-STIM NERVE STIMULATOR?

HILGER DUAL-STIM NERVE STIMULATOR is a medical device that received FDA 510(k) clearance on 2007-01-05. The listed applicant is Wr Medical Electronics Co.. The 510(k) number is K063560.

When did HILGER DUAL-STIM NERVE STIMULATOR receive FDA 510(k) clearance?

HILGER DUAL-STIM NERVE STIMULATOR received FDA 510(k) clearance on 2007-01-05, under 510(k) number K063560.

Who is the listed applicant for HILGER DUAL-STIM NERVE STIMULATOR?

The FDA 510(k) record lists Wr Medical Electronics Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HILGER DUAL-STIM NERVE STIMULATOR?

The FDA product code for HILGER DUAL-STIM NERVE STIMULATOR 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 Wr Medical Electronics Co. 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.

K092809HRV ACQUIREK000574IONTOPHORETIC DRUG DELIVERY ELECTRODE, IONTOPHORETIC ELECTRODE (ACTIVE)K992874Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEMK910624CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4K895838BRACKMANN EMG MONITORING SYSTEM

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.

↑