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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, Oxygen, Portable
510(k) Number K200496
Device Name Aer X
Applicant
3B Medical, Inc.
203 Ave. A NW, Suite 300
Winter,  FL  33881
Applicant Contact Yasser Estafanous
Correspondent
3B Medical, Inc.
203 Ave. A NW, Suite 300
Winter,  FL  33881
Correspondent Contact Yasser Estafanous
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/28/2020
Decision Date 07/24/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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