The following data is part of a premarket notification filed by Dima Italia Srl with the FDA for Negavent Plus Pegaso Cough, Model: Da-3 Plus.
| Device ID | K072292 |
| 510k Number | K072292 |
| Device Name: | NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | DIMA ITALIA SRL 4655 KIRKWOOD CT. Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward DIMA ITALIA SRL 4655 KIRKWOOD CT. Boulder, CO 80301 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-16 |
| Decision Date | 2008-01-07 |
| Summary: | summary |