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FDA 510(k)

CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE

K-Number: K050162 · 2005-03-03

ApplicantMedtronic Xomed, Inc.
Decision Date2005-03-03
Product CodeETN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2005-03-03 under 510(k) number K050162. 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 CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 2005-03-03. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K050162.

When did CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE received FDA 510(k) clearance on 2005-03-03, under 510(k) number K050162.

Who is the listed applicant for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

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

What is the FDA product code for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE?

The FDA product code for CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE is ETN.

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Other records listing Medtronic Xomed, Inc. as applicant

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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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