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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 Avenue A NW, Suite 300
Winter Haven,  FL  33881
Applicant Contact Yasser Estafanous
Correspondent
3B Medical Inc.
203 Avenue A NW, Suite 300
Winter Haven,  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
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