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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K221058
Device Name LungTrainer (MD2 & MD3)
Applicant
Lung Trainers, LLC
8000 NW 7 St., Suite 202
Miami,  FL  33126
Applicant Contact Frank Acosta
Correspondent
Medical Device Academy, Inc.
345
Lincoln Hill Rd.
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number868.5690
Classification Product Code
BWF  
Date Received04/11/2022
Decision Date 07/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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