Data / Medical devices / United States / Sentiar, Inc.
Sentiar, Inc.: FDA-registered device maker in Saint Louis, MO, United States, 2 510(k) clearances
Sentiar, Inc. is registered with the FDA (registration 3017435704) in Saint Louis, MO, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3017435704
- Address
- 212 N Kingshighway Blvd Suite 115, Box 28, Saint Louis, MO, United States, 63108
- Owner or operator
- SentiAR, Inc. (10077856)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 4, 2020
- Registered through
- 2026
- Brand names listed
- CommandEP, CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02), CommandEP HMD Custom Lens Insert (RXL01), SentiAR Data Manager PC (DPC03), SentiAR HMD (HMD03), SentiAR Wireless Access Point (WAP01)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Digital Image Communications, Radiological | LMD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 14, 2023 | K223290 | CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) | LLZ | Substantially Equivalent | Sentiar, Inc. | accessdata.fda.gov |
| September 18, 2020 | K192890 | SentEP | LLZ | Substantially Equivalent | Sentiar, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Digital Image Communications, Radiological
Updated July 14, 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.