The following data is part of a premarket notification filed by Liv Medica Products Pvt. Ltd. with the FDA for Liv Medica Cpr Face Mask.
| Device ID | K052458 |
| 510k Number | K052458 |
| Device Name: | LIV MEDICA CPR FACE MASK |
| Classification | Valve, Non-rebreathing |
| Applicant | LIV MEDICA PRODUCTS PVT. LTD. 458 BRIARCREEK DRIVE Hockessin, DE 19707 |
| Contact | Michael Holstein |
| Correspondent | Michael Holstein LIV MEDICA PRODUCTS PVT. LTD. 458 BRIARCREEK DRIVE Hockessin, DE 19707 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-07 |
| Decision Date | 2006-07-07 |