The following data is part of a premarket notification filed by Rondex Products, Inc. with the FDA for Rescue Mask & Cpr Valve For Mouth-to-mask Type Cpr.
| Device ID | K881931 |
| 510k Number | K881931 |
| Device Name: | RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR |
| Classification | Valve, Non-rebreathing |
| Applicant | RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford, IL 61110 |
| Contact | Gene R Baldwin |
| Correspondent | Gene R Baldwin RONDEX PRODUCTS, INC. P.O. BOX NO. 1829 Rockford, IL 61110 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-07-21 |