The following data is part of a premarket notification filed by Firstar Healthcare Company Limited (guangzhou) with the FDA for Cpr Face Shield.
| Device ID | K192285 |
| 510k Number | K192285 |
| Device Name: | CPR Face Shield |
| Classification | Valve, Non-rebreathing |
| Applicant | Firstar Healthcare Company Limited (Guangzhou) Rm.901, Building No.2,Headquarters Center, Tian’An High-Tech Ecological Park Guangzhou, CN 511400 |
| Contact | Alice Zhao |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.608,No.738,Shangcheng Rd.,Pudong Shanghai, CN 200120 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2020-11-25 |