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FDA 510(k)

NONDISPOSABLE STIMULATING INSTRUMENTS

K-Number: K121931 · 2012-10-19

ApplicantNeurovision Medical Products, Inc.
Decision Date2012-10-19
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NONDISPOSABLE STIMULATING INSTRUMENTS 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 2012-10-19 under 510(k) number K121931. 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 NONDISPOSABLE STIMULATING INSTRUMENTS?

NONDISPOSABLE STIMULATING INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2012-10-19. The listed applicant is Neurovision Medical Products, Inc.. The 510(k) number is K121931.

When did NONDISPOSABLE STIMULATING INSTRUMENTS receive FDA 510(k) clearance?

NONDISPOSABLE STIMULATING INSTRUMENTS received FDA 510(k) clearance on 2012-10-19, under 510(k) number K121931.

Who is the listed applicant for NONDISPOSABLE STIMULATING INSTRUMENTS?

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 NONDISPOSABLE STIMULATING INSTRUMENTS?

The FDA product code for NONDISPOSABLE STIMULATING INSTRUMENTS is ETN.

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Other records listing Neurovision Medical Products, Inc. as applicant

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K130570NEUROVISION MEDICAL MOTION SENSORK130806NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEK113771SIGNAL GEAR URETHRAL CATHETER ELECTRODEK110989NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODEK110140NEUROVISION NERVE LOCATOR MONITORK110712DRYTOUCH SUCTION STIMULATOR PROBE

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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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