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FDA 510(k)

NEUROVISION SE (NERVEANA)

K-Number: K102862 · 2010-12-21

ApplicantNeurovision Medical Products, Inc.
Decision Date2010-12-21
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NEUROVISION SE (NERVEANA) 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 2010-12-21 under 510(k) number K102862. 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 NEUROVISION SE (NERVEANA)?

NEUROVISION SE (NERVEANA) is a medical device that received FDA 510(k) clearance on 2010-12-21. The listed applicant is Neurovision Medical Products, Inc.. The 510(k) number is K102862.

When did NEUROVISION SE (NERVEANA) receive FDA 510(k) clearance?

NEUROVISION SE (NERVEANA) received FDA 510(k) clearance on 2010-12-21, under 510(k) number K102862.

Who is the listed applicant for NEUROVISION SE (NERVEANA)?

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 NEUROVISION SE (NERVEANA)?

The FDA product code for NEUROVISION SE (NERVEANA) is ETN.

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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

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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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