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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 K220622
Device Name Hailie Sensor NF0106
Applicant
Adherium (NZ) Ltd
Level 11, 16 Kingston Street
Auckland,  NZ 1010
Applicant Contact Geoff Feakes
Correspondent
Adherium (NZ) Ltd
Level 11, 16 Kingston Street
Auckland,  NZ 1010
Correspondent Contact Geoff Feakes
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/03/2022
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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