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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 K220145
Device Name Monaghan medical filtered mouthpiece kit
Applicant
Monaghan Medical Corporation
153 Industrial Blvd.
Plattsburgh,  NY  12901
Applicant Contact Cari J Reil
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number868.5630
Classification Product Code
CAF  
Date Received01/19/2022
Decision Date 08/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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