The following data is part of a premarket notification filed by Bmc Medical.,ltd. with the FDA for Viva Nasal Mask (model: Nm4), Numa Full Face Mask (model: Bmc-fm2).
| Device ID | K163464 |
| 510k Number | K163464 |
| Device Name: | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BMC MEDICAL.,LTD. ROOM 110 TOWER A FENGYU BUILDING, NO.115 FUCHENG RD Haidian, CN 100036 |
| Contact | Jiang Huiqi |
| Correspondent | Jiang Huiqi MID-LINK INTERNATIONAL 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 | 2016-12-09 |
| Decision Date | 2017-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16948538362119 | K163464 | 000 |
| 16948538360306 | K163464 | 000 |
| 16948538360313 | K163464 | 000 |
| 16948538360320 | K163464 | 000 |
| 16948538360337 | K163464 | 000 |
| 16948538360344 | K163464 | 000 |
| 16948538360351 | K163464 | 000 |
| 16948538360368 | K163464 | 000 |
| 16948538360375 | K163464 | 000 |
| 16948538360382 | K163464 | 000 |
| 06948538362082 | K163464 | 000 |
| 16948538362096 | K163464 | 000 |
| 06948538360293 | K163464 | 000 |