Data / Medical devices / United States / Semler Scientific, Inc.
Semler Scientific, Inc.: FDA-registered device maker in Campbell, CA, United States, 1 510(k) clearance
Semler Scientific, Inc. is registered with the FDA (registration 3008577991) in Campbell, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 5, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008577991
- Address
- 51 E Campbell Ave Ste 107d, Campbell, CA, United States, 95008
- Owner or operator
- Semler Scientific, Inc. (10032676)
- Roles
- Manufacturer
- First device listed
- November 30, 2015
- Registered through
- 2026
- Brand names listed
- QuantaFlo
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | JOM | 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 5, 2015 | K143094 | QuantaFlo | JOM | Substantially Equivalent | Semler Scientific, Inc. | accessdata.fda.gov |
Compare with other makers
Updated March 5, 2015. 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.