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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 K203155
Device Name BreatheSuite MDI V1
Applicant
Breathesuite, Inc.
29 Rowan St.
Unit 2
St. John'S,  CA A1B2X2
Applicant Contact Brett Vokey
Correspondent
Breathesuite, Inc.
29 Rowan St.
Unit 2
St. John'S,  CA A1B2X2
Correspondent Contact Brett Vokey
Regulation Number868.5630
Classification Product Code
CAF  
Date Received10/22/2020
Decision Date 09/17/2021
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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