The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Carhill One-way Resuscitation Valve.
| Device ID | K864681 |
| 510k Number | K864681 |
| Device Name: | CARHILL ONE-WAY RESUSCITATION VALVE |
| Classification | Valve, Non-rebreathing |
| Applicant | LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-02 |
| Decision Date | 1987-05-21 |