The following data is part of a premarket notification filed by Activaero America, Inc. with the FDA for Akita2 Apixneb.
| Device ID | K072019 |
| 510k Number | K072019 |
| Device Name: | AKITA2 APIXNEB |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ACTIVAERO AMERICA, INC. 3460 POINTE CREEK SUITE 102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ACTIVAERO AMERICA, INC. 3460 POINTE CREEK SUITE 102 Bonita Springs, FL 34134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-11-05 |
| Summary: | summary |