The following data is part of a premarket notification filed by 3b Medical, Inc. with the FDA for Luna G3 Bpap System.
| Device ID | K212263 |
| 510k Number | K212263 |
| Device Name: | Luna G3 BPAP System |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | 3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 |
| Contact | Yasser Estafanous |
| Correspondent | Yasser Estafanous 3B Medical, Inc. 203 Avenue A NW, Suite 300 Winter Haven, FL 33881 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-20 |
| Decision Date | 2022-03-25 |