The following data is part of a premarket notification filed by Dima Italia Srl with the FDA for Minipegaso Cough, Minipegaso A-cough, Minipegaso A-coug Perc.
| Device ID | K140605 |
| 510k Number | K140605 |
| Device Name: | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG 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 | 2014-10-03 |
| Summary: | summary |