FDA 510(k) K160127 iCodeConnect Submission by 3B MEDICAL, INC.

FDA 510(k) K160127 iCodeConnect Submission by 3B MEDICAL, INC.

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Device Classification Name  Ventilator, Non-Continuous (Respirator)
510(k) Number  K160127
Device Name  iCodeConnect
Applicant  3B MEDICAL, INC.
Regulation Number  868.5905
Classification Product Code  BZD 
Date Received  01/20/2016
Decision Date  11/10/2016
Decision  Substantially Equivalent (SESE)
Regulation Medical Specialty  Anesthesiology

Total pages: 2,076
Fully redacted pages: 1,732
Content pages: 344

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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