The following data is part of a premarket notification filed by Evit Labs, Inc. with the FDA for Sonik Ldi 20 Air.
| Device ID | K030374 |
| 510k Number | K030374 |
| Device Name: | SONIK LDI 20 AIR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | EVIT LABS, INC. 4843 46TH STREET, BUILDING 351 Mcclellan, CA 95652 |
| Contact | S. David Piper |
| Correspondent | S. David Piper EVIT LABS, INC. 4843 46TH STREET, BUILDING 351 Mcclellan, CA 95652 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-04 |
| Decision Date | 2003-08-25 |