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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 K221014
Device Name Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
Applicant
Effortless Oxygen. LLC
251 E Sierra Dr.
Phoenix,  AZ  85012
Applicant Contact Samir Ahmad
Correspondent
Effortless Oxygen. LLC c/o Promedic, LLC
131 Bay Point Dr NE
Saint Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5905
Classification Product Code
NFB  
Date Received04/05/2022
Decision Date 10/17/2022
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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