Data / Medical devices / Israel / Graymatters Health
Graymatters Health: FDA-registered device maker in Haifa, Israel, 1 510(k) clearance
Graymatters Health is registered with the FDA (registration 3029924306) in Haifa, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029924306
- Address
- Haazmaut 82, Haifa, Israel, 340072
- Owner or operator
- GrayMatters Health (10089026)
- Roles
- Manufacturer
- First device listed
- October 30, 2023
- Registered through
- 2026
- Brand names listed
- Prism
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 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 17, 2023 | K222101 | Prism | HCC | Substantially Equivalent | Graymatters Health , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 17, 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.