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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 K201167
Device Name AireHealth NebulizerTM
Applicant
AireHealth Inc.
3251 Progess Dr., Suite F
Orlando,  FL  32826
Applicant Contact Rusty Kelly
Correspondent
Regulatory and Quality Solutions, LLC
2790 Mosside Blvd #800
Monroeville,  PA  15146
Correspondent Contact Jessica Czamanski
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/01/2020
Decision Date 12/03/2020
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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