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FDA 510(k) Applications Submitted by 3B MEDICAL, INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160127
01/20/2016
iCodeConnect
3B MEDICAL, INC.
K153387
11/23/2015
Luna CPAP and Auto CPAP System
3B MEDICAL, INC.
K201620
06/15/2020
Luna« G3 BPAP 25A
3B Medical, Inc.
K212263
07/20/2021
Luna G3 BPAP System
3B Medical, Inc.
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