The following data is part of a premarket notification filed by Activaero America, Inc. with the FDA for Akita Jet.
| Device ID | K090730 |
| 510k Number | K090730 |
| Device Name: | AKITA JET |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ACTIVAERO AMERICA, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ACTIVAERO AMERICA, INC. 24301 WOODSAGE DRIVE 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 | 2009-03-19 |
| Decision Date | 2009-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05056143200451 | K090730 | 000 |
| 05056143200154 | K090730 | 000 |
| 05056143200123 | K090730 | 000 |
| 05056143200116 | K090730 | 000 |
| 05056143200109 | K090730 | 000 |
| 05056143200093 | K090730 | 000 |