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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 K192307
Device Name Nihon Kohden NKV-550 Series Ventilator System
Applicant
Nihon Kohden Orangemed, Inc.
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Applicant Contact Sheryl Higgins
Correspondent
Nihon Kohden Orangemed, Inc.
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Correspondent Contact Sheryl Higgins
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/26/2019
Decision Date 01/10/2020
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
Recalls CDRH Recalls
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