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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, Minimal Ventilatory Support, Facility Use
510(k) Number K213521
Device Name Nihon Kohden NKV-330 Ventilator System
Applicant
Nihon Kohden Orangemed, Inc.
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Applicant Contact Jacqueline Villanueva
Correspondent
Nihon Kohden Orangemed, Inc.
1800 E. Wilshire Ave.
Santa Ana,  CA  92705
Correspondent Contact Jacqueline Villanueva
Regulation Number868.5895
Classification Product Code
MNT  
Date Received11/03/2021
Decision Date 07/01/2022
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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