FDA 510(k) K203362, TRACOE vario, by Tracoe Medical GmbH

FDA 510(k) K203362, TRACOE vario, by Tracoe Medical GmbH

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Device Classification Name: Tube Tracheostomy And Tube Cuff
510(k) Number: K203362
Device Name: TRACOE vario
Applicant: Tracoe Medical GmbH
Regulation Number: 868.5800
Classification Product Code: JOH
Date Received: 11/16/2020
Decision Date: 08/05/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology

Total number of pages: 2,523
Fully redacted pages: 1,973
Content pages: 550

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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