Data / Medical devices / United States / Calla Health Foundation
Calla Health Foundation: FDA-registered device maker in Durham, NC, United States, 1 510(k) clearance
Calla Health Foundation is registered with the FDA (registration 3016965604) in Durham, NC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 21, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016965604
- Address
- 701 W Main St Ste 200, Durham, NC, United States, 27701
- Owner or operator
- Calla Health Foundation (10075188)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- June 8, 2020
- Registered through
- 2026
- Brand names listed
- Pocket Colposcope
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Colposcope (And Colpomicroscope) | HEX | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| September 21, 2018 | K181034 | Pocket Colposcope System | HEX | Substantially Equivalent | Hadleigh Health Technologies, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 21, 2018. 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.