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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K201620
Device Name Luna® G3 BPAP 25A
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 Number868.5905
Classification Product Code
BZD  
Date Received06/15/2020
Decision Date 01/29/2021
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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