The following data is part of a premarket notification filed by Bmc Medical Co., Ltd. with the FDA for Auto Cpap System.
| Device ID | K211155 |
| 510k Number | K211155 |
| Device Name: | Auto CPAP System |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BMC Medical Co., Ltd. Room 901, Building 1, No. 28 Pingguoyuan Road Beijing, CN 100041 |
| Contact | Amy Wang |
| Correspondent | Amy Wang BMC Medical Co., Ltd. Room 901, Building 1, No. 28 Pingguoyuan Road Beijing, CN 100041 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-19 |
| Decision Date | 2022-03-09 |