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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K223452
Device Name Nitronox Scavenger Plus
Applicant
Parker Hannifin Corporation
245 Township Line Road
Hatfield,  PA  19440
Applicant Contact Dylan Alu
Correspondent
Parker Hannifin Corporation
245 Township Line Road
Hatfield,  PA  19440
Correspondent Contact Dylan Alu
Regulation Number868.5430
Classification Product Code
CBN  
Date Received11/15/2022
Decision Date 03/05/2023
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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