Data / Medical devices / United States / Perimetrics, Inc
Perimetrics, Inc: FDA-registered device maker in Santa Ana, CA, United States, 1 510(k) clearance
Perimetrics, Inc is registered with the FDA (registration 3039642990) in Santa Ana, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039642990
- Address
- 2961 W MacArthur Blvd, Suite 121, Santa Ana, CA, United States, 92704
- Owner or operator
- Perimetrics, Inc (9058882)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- June 11, 2024
- Registered through
- 2026
- Brand names listed
- InnerView System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | 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 |
|---|---|---|---|---|---|---|
| September 1, 2023 | K232657 | InnerView LC | EKX | Substantially Equivalent | Perimetrics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 1, 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.