The following data is part of a premarket notification filed by Bmc Medical Co., Ltd with the FDA for Nasal Mask, Nasal Mask, Full Face Mask.
| Device ID | K133009 |
| 510k Number | K133009 |
| Device Name: | NASAL MASK, NASAL MASK, FULL FACE MASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BMC MEDICAL CO., LTD 5/F Main Building No.19 Gucheng Street West,Shijingshan Beijing, CN 100043 |
| Contact | Ms. Jinjing |
| Correspondent | Ms. Jinjing BMC MEDICAL CO., LTD 5/F Main Building No.19 Gucheng Street West,Shijingshan Beijing, CN 100043 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2014-04-23 |
| Summary: | summary |