Data / Medical devices / Italy / Dima Italia SRL
Dima Italia SRL: FDA-registered device maker in Bologna, Italy, 3 510(k) clearances
Dima Italia SRL is registered with the FDA (registration 3007123976) in Bologna, Italy. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 16, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007123976
- Address
- via Coriolano Vighi, 29, Bologna, Italy, 40133
- Owner or operator
- dima italia srl (10026310)
- Roles
- Manufacturer
- First device listed
- July 2, 2008
- Registered through
- 2026
- Brand names listed
- COR-0000010, COR-0000020, COR-0000030, COR-0000040, COR-0000050, COR-0000060, COR-0000070, COR-0000080 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Positive Pressure Breathing, Intermittent | NHJ | 2 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, External Body, Negative Pressure, Adult (Cuirass) | BYT | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 16, 2014 | K140598 | PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC | NHJ | Substantially Equivalent | Dima Italia Srl | accessdata.fda.gov |
| October 3, 2014 | K140605 | MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC | NHJ | Substantially Equivalent | Dima Italia Srl | accessdata.fda.gov |
| May 29, 2008 | K072290 | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS | BYT | Substantially Equivalent | Dima Italia Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- All makers of Device, Positive Pressure Breathing, Intermittent
Updated October 16, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.