The following data is part of a premarket notification filed by Ipax, Inc. with the FDA for Surebreath Dome, E-z Breather.
| Device ID | K915158 |
| 510k Number | K915158 |
| Device Name: | SUREBREATH DOME, E-Z BREATHER |
| Classification | Retractor |
| Applicant | IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Contact | Phillip Pennell |
| Correspondent | Phillip Pennell IPAX, INC. 2109 WEST AMHERST AVE. Englewood, CO 80110 |
| Product Code | GAD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-14 |
| Decision Date | 1992-02-12 |