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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 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 Number868.5905
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
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