Data / Medical devices / United States / Talis Clinical LLC
Talis Clinical LLC: FDA-registered device maker in Richfield, OH, United States, 1 510(k) clearance
Talis Clinical LLC is registered with the FDA (registration 3012103976) in Richfield, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 1, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012103976
- Address
- 4125 Highlander Pkwy Ste 110, Richfield, OH, United States, 44286
- Owner or operator
- Talis Clinical LLC (10050330)
- Roles
- Manufacturer
- First device listed
- September 13, 2024
- Registered through
- 2027
- Brand names listed
- Talis EMR with +ACG
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 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 |
|---|---|---|---|---|---|---|
| April 1, 2024 | K233133 | Talis EMR with Talis +ACG (Talis EMR with +ACG) | MWI | Substantially Equivalent | Talis Clinical, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 1, 2024. 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.