The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Sleepap.
| Device ID | K905593 |
| 510k Number | K905593 |
| Device Name: | SLEEPAP |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel, IA 50003 |
| Contact | Russell F Bird |
| Correspondent | Russell F Bird MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel, IA 50003 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-13 |
| Decision Date | 1991-04-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SLEEPAP 88016916 5675137 Live/Registered |
Encompass Group, LLC 2018-06-27 |