Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K212263 |
Device Name |
Luna G3 BPAP System |
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 Number | 868.5905
|
Classification Product Code |
|
Date Received | 07/20/2021 |
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
|
|
|