The following data is part of a premarket notification filed by Diagnostic Devices, Inc. with the FDA for Ddi Ultrasonic Nebulizer System.
| Device ID | K090307 |
| 510k Number | K090307 |
| Device Name: | DDI ULTRASONIC NEBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DIAGNOSTIC DEVICES, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j Smith |
| Correspondent | E.j Smith DIAGNOSTIC DEVICES, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-06 |
| Decision Date | 2009-06-18 |
| Summary: | summary |