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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K222247
Device Name Hailie Sensor NF0110
Applicant
Adherium (NZ) Ltd
Level 11, 16 Kingston Street
Auckland,  NZ 1010
Applicant Contact Tara Creaven-Capasso
Correspondent
Adherium (NZ) Ltd
Level 11, 16 Kingston Street
Auckland,  NZ 1010
Correspondent Contact Tara Creaven-Capasso
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/26/2022
Decision Date 02/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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