The following data is part of a premarket notification filed by Medsource International, Llc. with the FDA for Medsource Cpr Mask With & Without Oxygen Port.
| Device ID | K081516 |
| 510k Number | K081516 |
| Device Name: | MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT |
| Classification | Valve, Non-rebreathing |
| Applicant | MEDSOURCE INTERNATIONAL, LLC. 5346 SHORELINE DR. Mound, MN 55364 |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-30 |
| Decision Date | 2008-08-26 |
| Summary: | summary |