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510(k) K222644

Nihon Kohden NKV-440 Ventilator System by Nihon Kohden Orangemed, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2023
Date Received
September 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Nihon Kohden Orangemed, Inc.

  • K231778 — Nihon Kohden NKV-550 Series Ventilator System (March 1, 2024)
  • K213521 — Nihon Kohden NKV-330 Ventilator System (July 1, 2022)
  • K192307 — Nihon Kohden NKV-550 Series Ventilator System (January 10, 2020)
  • K181695 — Nihon Kohden NKV-550 Series Ventilator System (December 7, 2018)

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