The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Sleepap Mask.
| Device ID | K894642 |
| 510k Number | K894642 |
| Device Name: | SLEEPAP MASK |
| Classification | Mask, Oxygen |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 713 - 52ND ST. West Des Moines, IA 50265 |
| Contact | Russell Bird |
| Correspondent | Russell Bird MEDICAL INDUSTRIES AMERICA, INC. 713 - 52ND ST. West Des Moines, IA 50265 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-19 |