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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