Data / Medical devices / United States / Agilemd
Agilemd: FDA-registered device maker in Cupertino, CA, United States, 1 510(k) clearance
Agilemd is registered with the FDA (registration 3031823069) in Cupertino, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated June 21, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031823069
- Address
- 10080 N. Wolfe Rd., Suite SW3-229, Cupertino, CA, United States, 95014
- Owner or operator
- AgileMD (10091218)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- July 25, 2024
- Registered through
- 2026
- Brand names listed
- eCART, eCARTv5, eCARTv5 Clinical Deterioration Suite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medium-Term Adjunctive Predictive Cardiovascular Indicator | QNL | 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 |
|---|---|---|---|---|---|---|
| June 21, 2024 | K233253 | eCARTv5 Clinical Deterioration Suite (eCART) | QNL | Substantially Equivalent | Agilemd, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 21, 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.