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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Breathing Gases, Anesthesia Inhalation
510(k) Number K202480
Device Name Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
Applicant
Parker Hannifin
245 Township Line Rd.
Hatfield,  PA  19440
Applicant Contact Andrew Ellinger
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number868.5330
Classification Product Code
BZR  
Date Received08/28/2020
Decision Date 04/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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