The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for 3002 Aeromax.
| Device ID | K942444 |
| 510k Number | K942444 |
| Device Name: | 3002 AEROMAX |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2879 R AVE. Adel, IA 50003 -8055 |
| Contact | Mark D Hebenstreit |
| Correspondent | Mark D Hebenstreit MEDICAL INDUSTRIES AMERICA, INC. 2879 R AVE. Adel, IA 50003 -8055 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-23 |
| Decision Date | 1995-03-10 |