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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 Point 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
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