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