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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K231778
Device Name Nihon Kohden NKV-550 Series Ventilator System
Applicant
Nihon Kohden Orangemed, LLC
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Applicant Contact Sheryl Higgins
Correspondent
Nihon Kohden Orangemed, LLC
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Correspondent Contact Sheryl Higgins
Regulation Number868.5895
Classification Product Code
CBK  
Date Received06/16/2023
Decision Date 03/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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