FDA 510(k) K112686, NEXT GEN EMG ENDOTRACHEAL TUBE, by Medtronic Xomed, Inc.

FDA 510(k) K112686, NEXT GEN EMG ENDOTRACHEAL TUBE, by Medtronic Xomed, Inc.

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Device Classification Name: Stimulator, Nerve
510(k) Number: K112686
Device Name: NEXT GEN EMG ENDOTRACHEAL TUBE
Applicant: Medtronic Xomed, Inc.
Regulation Number: 874.182
Classification Product Code: ETN
Date Received: 2011-09-15
Decision Date: 2012-06-27
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
510k Review Panel: Ear Nose & Throat

Total number of pages: 733
Fully redacted pages: 480
Content pages: 253

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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