The following data is part of a premarket notification filed by San Up S.a. with the FDA for San Up S.a. Nebulizer Compressor, With Disposable Nebulizer, Model 3050.
| Device ID | K002468 |
| 510k Number | K002468 |
| Device Name: | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 |
| Classification | Compressor, Air, Portable |
| Applicant | SAN UP S.A. 55 NOTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk SAN UP S.A. 55 NOTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-11 |
| Decision Date | 2001-03-02 |