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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Conserver, Oxygen
510(k) Number K200401
Device Name Apogee
Applicant
Incoba Ltd D/B/A Dynaris
Spirit 40 Park Dr.
Suite 260
Chesterfield,  MO  63005
Applicant Contact Lon Aylsworth
Correspondent
Incoba Ltd D/B/A Dynaris % Promedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
NFB  
Date Received02/18/2020
Decision Date 11/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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