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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Percussor, Powered-Electric
510(k) Number K201490
Device Name Electro Flo 6 Airway Clearance System
Applicant
Med Systems, Inc.
2631 Ariane Drive
San Diego,  CA  92117
Applicant Contact Susan B Davis
Correspondent
BioMedical Strategies
133 Colonial Dr.
White River Junction,  VT  05001
Correspondent Contact Frederick Cahn
Regulation Number868.5665
Classification Product Code
BYI  
Date Received06/04/2020
Decision Date 02/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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