The following data is part of a premarket notification filed by Med2000 S.r.l. with the FDA for Med2000 Spa Nebulizer Compressors, Models P1 And P2, With Nebulizer, And Med2000 Spa Nebulizer, Model A1/c (andyflow).
| Device ID | K031908 |
| 510k Number | K031908 |
| Device Name: | MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MED2000 S.R.L. 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MED2000 S.R.L. 55 NORTHERN BLVD., STE 200 Great Neck, NY 11021 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-20 |
| Decision Date | 2004-01-14 |
| Summary: | summary |