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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 K212263
Device Name Luna G3 BPAP System
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 Received07/20/2021
Decision Date 03/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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