Data / Medical devices / United States / Sutter Health
Sutter Health: FDA-registered device maker in Sacramento, CA, United States, 1 510(k) clearance
Sutter Health is registered with the FDA (registration 3013543897) in Sacramento, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 28, 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
- 3013543897
- Address
- 2200 River Plaza Dr, Sacramento, CA, United States, 95833
- Owner or operator
- Sutter Health (10093765)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- August 15, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| November 28, 2023 | K232713 | Blood Pressure Monitor | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated November 28, 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.