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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 K221994
Device Name Hailie Sensor NF0107 & NF0108
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 Received07/06/2022
Decision Date 10/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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