The following data is part of a premarket notification filed by Khi, Inc. with the FDA for Emergiency Resuscitator/inhalor W/aspir..
| Device ID | K800456 |
| 510k Number | K800456 |
| Device Name: | EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR. |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | KHI, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-29 |
| Decision Date | 1980-03-18 |