The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Transneb Compressor W/nebulizer, Model 5000.
| Device ID | K032170 |
| 510k Number | K032170 |
| Device Name: | TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 2636 289TH PLACE Adel, IA 50003 -8021 |
| Contact | Anne B Carlson |
| Correspondent | Ned E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-16 |
| Decision Date | 2004-05-28 |
| Summary: | summary |