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FDA 510(k)

NERVE INTEGRITY MONITOR-2 (NIM-2 XL)

K-Number: K934426 · 1994-05-13

ApplicantXomed-Treace, Inc.
Decision Date1994-05-13
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NERVE INTEGRITY MONITOR-2 (NIM-2 XL) is the device name listed in this FDA 510(k) record. The listed applicant is Xomed-Treace, Inc.. It received FDA 510(k) clearance on 1994-05-13 under 510(k) number K934426. 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 INTEGRITY MONITOR-2 (NIM-2 XL)?

NERVE INTEGRITY MONITOR-2 (NIM-2 XL) is a medical device that received FDA 510(k) clearance on 1994-05-13. The listed applicant is Xomed-Treace, Inc.. The 510(k) number is K934426.

When did NERVE INTEGRITY MONITOR-2 (NIM-2 XL) receive FDA 510(k) clearance?

NERVE INTEGRITY MONITOR-2 (NIM-2 XL) received FDA 510(k) clearance on 1994-05-13, under 510(k) number K934426.

Who is the listed applicant for NERVE INTEGRITY MONITOR-2 (NIM-2 XL)?

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

What is the FDA product code for NERVE INTEGRITY MONITOR-2 (NIM-2 XL)?

The FDA product code for NERVE INTEGRITY MONITOR-2 (NIM-2 XL) is ETN.

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Other records listing Xomed-Treace, 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.

K940028ENDOSCOPE SHEATHK941407TYMPANOSTOMY (VENTILATION) TUBEK945659BLACKSTAR(TM) STAR SYSTEMK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEK933672XOMED-TREACE SCOPESHEATHK933105XOMED-TREACE RIGID ROD LENS ENDOSCOPE

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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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