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FDA 510(k)

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

K-Number: K053141 · 2005-12-14

ApplicantThe Magstim Company , Ltd.
Decision Date2005-12-14
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 is the device name listed in this FDA 510(k) record. The listed applicant is The Magstim Company , Ltd.. It received FDA 510(k) clearance on 2005-12-14 under 510(k) number K053141. 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 NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800?

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 is a medical device that received FDA 510(k) clearance on 2005-12-14. The listed applicant is The Magstim Company , Ltd.. The 510(k) number is K053141.

When did NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 receive FDA 510(k) clearance?

NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 received FDA 510(k) clearance on 2005-12-14, under 510(k) number K053141.

Who is the listed applicant for NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800?

The FDA 510(k) record lists The Magstim Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800?

The FDA product code for NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800 is ETN.

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Other records listing The Magstim Company , Ltd. 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.

K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide ProK130403MAGSTIM DOUBLE 70-2 COILK083242NEUROSIGN AVALANCHE MOTOR NERVE MONITORK080499MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00K071349NEUROSIGN LARYNGEAL ELECTRODESK051864MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00

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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.

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