Data / Medical devices / Italy / C.S.O. S.R.L.
C.S.O. S.R.L.: FDA-registered device maker in Scandicci Firenze, Italy, 5 510(k) clearances
C.S.O. S.R.L. is registered with the FDA (registration 8020986) in Scandicci Firenze, Italy. It lists 13 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8020986
- FEI number
- 4196
- Address
- Via Degli Stagnacci 12/E, Scandicci Firenze, Italy, 50018
- Owner or operator
- C.S.O. S.R.L. (8020987)
- Roles
- Manufacturer
- First device listed
- October 21, 1999
- Registered through
- 2026
- Brand names listed
- A900, F900, Antares, Antares+, C.S.O. CHAIR, C.S.O. CHART PROJECTOR, C.S.O. INSTRUMENT TABLE, C.S.O. REFRACTING UNIT, CORNEA550 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | 2 | Manufacturer | accessdata.fda.gov |
| Camera, Ophthalmic, Ac-Powered | HKI | 2 | Manufacturer | accessdata.fda.gov |
| Chair, Ophthalmic, Ac-Powered | HME | 1 | Manufacturer | accessdata.fda.gov |
| Device, Analysis, Anterior Segment | MXK | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Measuring, Lens, Ac-Powered | HLM | 1 | Manufacturer | accessdata.fda.gov |
| Keratoscope, Ac-Powered | HLQ | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | 1 | Manufacturer | accessdata.fda.gov |
| Microscope, Surgical | EPT | 1 | Manufacturer | accessdata.fda.gov |
| Projector, Ophthalmic | HOS | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | 1 | Manufacturer | accessdata.fda.gov |
| Table, Instrument, Powered, Ophthalmic | HRJ | 1 | Manufacturer | accessdata.fda.gov |
| Tomography, Optical Coherence | OBO | 2 | Manufacturer | accessdata.fda.gov |
| Tonometer, Manual | HKY | 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 |
|---|---|---|---|---|---|---|
| September 1, 2023 | K221601 | MS-39 | OBO | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| July 3, 2014 | K132987 | COBRA FUNDUS CAMERA | HKI | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| August 6, 2002 | K022054 | F 900 | HKY | Substantially Equivalent | C.S.O. S.R.L. | accessdata.fda.gov |
| June 6, 2000 | K992835 | C.S.O. TONOMETER | HKY | Substantially Equivalent | Cso | accessdata.fda.gov |
| November 9, 1999 | K992836 | SL990, SL980, SL950 | HJO | Substantially Equivalent | Cso | accessdata.fda.gov |
Compare with other makers
- All makers of Tonometer, Manual
- All makers of Stand, Instrument, Ac-Powered, Ophthalmic
- All makers of Chair, Ophthalmic, Ac-Powered
- All makers of Keratoscope, Ac-Powered
- All makers of Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
- All makers of Microscope, Surgical
Updated September 1, 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.