Data / Medical devices / Italy / Mir - Medical International Research S.P.A.
Mir - Medical International Research S.P.A.: FDA-registered device maker in Roma, Italy, 7 510(k) clearances
Mir - Medical International Research S.P.A. is registered with the FDA (registration 9614860) in Roma, Italy. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614860
- FEI number
- 3004612204
- Address
- Viale Luigi Schiavonetti, 270, Roma, Italy, 00173
- Owner or operator
- MIR MEDICAL INTL. RESEARCH S.P.A. (9034107)
- Roles
- Manufacturer
- First device listed
- December 6, 2007
- Registered through
- 2026
- Brand names listed
- AsthmaTuner, Cohero - cSpirometer, Cohero - mSpirometer, FlowMIR, FlowMIR Plus, Minispir, Minispir PLUS, Minispir PLUS ESI and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Meter, Peak Flow, Spirometry | BZH | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 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 |
|---|---|---|---|---|---|---|
| December 15, 2023 | K230501 | Spirobank Oxi | BZG | Substantially Equivalent | Mir Medical International Research USA | accessdata.fda.gov |
| August 1, 2018 | K181666 | Smart One | BZH | Substantially Equivalent | Mir Medical International Research | accessdata.fda.gov |
| October 30, 2013 | K130784 | SPIROTEL | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
| October 4, 2012 | K122384 | MINISPIR | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
| November 21, 2011 | K103530 | SPIRODOC | BZG | Substantially Equivalent | Medical International Research USA, Inc. | accessdata.fda.gov |
| December 26, 2007 | K072979 | SPIROBANK G | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
| December 1, 2006 | K061712 | SPIROBANK II | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Meter, Peak Flow, Spirometry
- All makers of Spirometer, Diagnostic
- All makers of Oximeter
- All makers of Mouthpiece, Breathing
Updated December 15, 2023. 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.