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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 K222644
Device Name Nihon Kohden NKV-440 Ventilator System
Applicant
Nihon Kohden OrangeMed, Inc.
1800 E. Wilshire Avenue
Santa Ana,  CA  92705
Applicant Contact Sheryl Higgins
Correspondent
Nihon Kohden OrangeMed, Inc.
1800 E. Wilshire Avenue
Santa Ana,  CA  92705
Correspondent Contact Sheryl Higgins
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/01/2022
Decision Date 05/31/2023
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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