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FDA 510(k) Applications Submitted by Nihon Kohden OrangeMed, Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K213521
11/03/2021
Nihon Kohden NKV-330 Ventilator System
Nihon Kohden OrangeMed, Inc.
K181695
06/27/2018
Nihon Kohden NKV-550 Series Ventilator System
Nihon Kohden OrangeMed, Inc.
K192307
08/26/2019
Nihon Kohden NKV-550 Series Ventilator System
Nihon Kohden OrangeMed, Inc.
K222644
09/01/2022
Nihon Kohden NKV-440 Ventilator System
Nihon Kohden OrangeMed, Inc.
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