The following data is part of a premarket notification filed by Xiamen Compower Medical Tech. Co. Ltd. with the FDA for Compower Cpr Mask With Oxygen Port, Compower Cpr Mask Without Oxygen Port, Compower Infant Cpr Mask, Compower Non-rebreathing Valve (22mm/15mmod), Non-rebreathing Valve (22mm/18.5mm).
| Device ID | K171961 |
| 510k Number | K171961 |
| Device Name: | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm) |
| Classification | Valve, Non-rebreathing |
| Applicant | Xiamen Compower Medical Tech. Co. Ltd. Unit 301, No.16 Xianghong Road, Xiang'an Torch Industrial Zone Xiamen, CN 361101 |
| Contact | Lifen Chen |
| Correspondent | Lynn Jensen NAMSA 400 Highway 169 South Suite 500 Minneapolis, MN 55426 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-30 |
| Decision Date | 2017-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26946430400288 | K171961 | 000 |
| 16946430410280 | K171961 | 000 |
| 16946430410396 | K171961 | 000 |
| 20193489021414 | K171961 | 000 |
| 16946430414370 | K171961 | 000 |
| 16946430415186 | K171961 | 000 |
| 16946430415216 | K171961 | 000 |
| 06946430415202 | K171961 | 000 |
| 00814940021564 | K171961 | 000 |
| 16946430415391 | K171961 | 000 |
| 06946430400161 | K171961 | 000 |
| 16946430400182 | K171961 | 000 |
| 26946430400271 | K171961 | 000 |
| 16946430400267 | K171961 | 000 |
| 16946430400250 | K171961 | 000 |
| 16946430400243 | K171961 | 000 |
| 16946430400236 | K171961 | 000 |
| 16946430400229 | K171961 | 000 |
| 16946430400212 | K171961 | 000 |
| 16946430400205 | K171961 | 000 |
| 16946430400199 | K171961 | 000 |
| 16946430415827 | K171961 | 000 |