The following data is part of a premarket notification filed by Bawmed Uk with the FDA for Bawmed Rescue Mask.
| Device ID | K031431 |
| 510k Number | K031431 |
| Device Name: | BAWMED RESCUE MASK |
| Classification | Valve, Non-rebreathing |
| Applicant | BAWMED UK 6 GREAT HOUSE MEADOWS United Kingdom, GB Cf61 Isu. |
| Contact | Barbara Woods |
| Correspondent | Barbara Woods BAWMED UK 6 GREAT HOUSE MEADOWS United Kingdom, GB Cf61 Isu. |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2004-07-13 |