The following data is part of a premarket notification filed by Firstar Healthcare Co., Ltd. with the FDA for Cpr Mask.
| Device ID | K083418 |
| 510k Number | K083418 |
| Device Name: | CPR MASK |
| Classification | Valve, Non-rebreathing |
| Applicant | FIRSTAR HEALTHCARE CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Yovette Mumford |
| Correspondent | Yovette Mumford FIRSTAR HEALTHCARE CO., LTD. 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-18 |
| Decision Date | 2010-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B448FS1041 | K083418 | 000 |
| B859ERM1010 | K083418 | 000 |