The following data is part of a premarket notification filed by Xiamen Compower Medical Tech. Co., Ltd. with the FDA for Disposable Manual Resuscitator.
| Device ID | K210288 |
| 510k Number | K210288 |
| Device Name: | Disposable Manual Resuscitator |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | Mingzi Hussey Zi-medical, Inc. 93 Springs Rd Bedford, MA 01730 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-02 |
| Decision Date | 2021-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06946430410887 | K210288 | 000 |
| 06946430421579 | K210288 | 000 |
| 16946430413663 | K210288 | 000 |
| 16946430413649 | K210288 | 000 |
| 16946430413656 | K210288 | 000 |
| 16946430410839 | K210288 | 000 |
| 16946430410846 | K210288 | 000 |
| 16946430410853 | K210288 | 000 |
| 16946430410860 | K210288 | 000 |
| 16946430410877 | K210288 | 000 |
| 16946430421583 | K210288 | 000 |