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FDA 510(k)

NERVE LOCATOR/MONITOR SYSTEM MODIFICATION

K-Number: K954601 · 1995-12-22

ApplicantRln Systems, Inc.
Decision Date1995-12-22
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NERVE LOCATOR/MONITOR SYSTEM MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Rln Systems, Inc.. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K954601. 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 NERVE LOCATOR/MONITOR SYSTEM MODIFICATION?

NERVE LOCATOR/MONITOR SYSTEM MODIFICATION is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Rln Systems, Inc.. The 510(k) number is K954601.

When did NERVE LOCATOR/MONITOR SYSTEM MODIFICATION receive FDA 510(k) clearance?

NERVE LOCATOR/MONITOR SYSTEM MODIFICATION received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954601.

Who is the listed applicant for NERVE LOCATOR/MONITOR SYSTEM MODIFICATION?

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

What is the FDA product code for NERVE LOCATOR/MONITOR SYSTEM MODIFICATION?

The FDA product code for NERVE LOCATOR/MONITOR SYSTEM MODIFICATION 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 Rln Systems, 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.

K003745LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ETK925008RLN NERVE LOCATOR/MONITOR; MODEL AK912508NERVE LOCATOR/MONITOR SYSTEM, MODIFICATIONK895676HEMOSTAT/STIMULATOR PROBE

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

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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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