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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 K223367
Device Name Ochsner Connected Inhaler Sensor
Applicant
Ochsner Clinic Foundation
1514 Jefferson Hwy
New Orleans,  LA  70121
Applicant Contact Hakm Murad
Correspondent
Ochsner Clinic Foundation
1514 Jefferson Hwy
New Orleans,  LA  70121
Correspondent Contact Hakm Murad
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/04/2022
Decision Date 08/30/2023
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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