The following data is part of a premarket notification filed by Med2000 S.r.l. with the FDA for Med2000 Nebulizer Compressor, Models P3, P4, P5 With Nebulizer.
| Device ID | K041974 |
| 510k Number | K041974 |
| Device Name: | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER |
| Classification | Compressor, Air, Portable |
| 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 | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-22 |
| Decision Date | 2004-08-24 |
| Summary: | summary |