The following data is part of a premarket notification filed by Dima Italia Srl with the FDA for Pegaso Cough, Pegaso A-cough, Pegaso A-cough Perc.
| Device ID | K140598 |
| 510k Number | K140598 |
| Device Name: | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | DIMA ITALIA SRL via Coriolano Vighi, 29 Bologna, IT 40133 |
| Contact | Dario Basciu |
| Correspondent | Dario Basciu DIMA ITALIA SRL via Coriolano Vighi, 29 Bologna, IT 40133 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-10-16 |
| Summary: | summary |