The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Evolution Ultrasonic.
| Device ID | K894215 |
| 510k Number | K894215 |
| Device Name: | EVOLUTION ULTRASONIC |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| 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 | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-19 |
| Decision Date | 1990-04-16 |