Data / Medical devices / United States / Neosoft, LLC
Neosoft, LLC: FDA-registered device maker in Pewaukee, WI, United States, 1 510(k) clearance
Neosoft, LLC is registered with the FDA (registration 3005914761) in Pewaukee, WI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 20, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005914761
- Address
- N27W23910A Paul Road, Pewaukee, WI, United States, 53072
- Owner or operator
- NeoSoft, LLC (10044333)
- Roles
- Manufacturer
- First device listed
- May 28, 2013
- Registered through
- 2026
- Brand names listed
- suiteHEART
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 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 |
|---|---|---|---|---|---|---|
| March 20, 2013 | K130228 | SUITEHEART | LLZ | Substantially Equivalent | Neosoft, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 20, 2013. 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.