Data / Medical devices / United States / Ehmet Health
Ehmet Health: FDA-registered device maker in Plymouth, MI, United States, 1 510(k) clearance
Ehmet Health is registered with the FDA (registration 3016872563) in Plymouth, MI, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016872563
- Address
- 47801 W Anchor Ct, Plymouth, MI, United States, 48170
- Owner or operator
- Ehmet Health (10073828)
- Roles
- Manufacturer
- First device listed
- May 14, 2020
- Registered through
- 2026
- Brand names listed
- X-ray Imaging System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Radiation Therapy, Charged-Particle, Medical | LHN | 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 |
|---|---|---|---|---|---|---|
| December 10, 2018 | K181498 | X-ray Imaging System for the McLaren Proton Treatment System | LHN | Substantially Equivalent | Ehmetdx, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 10, 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.