Data / Medical devices / United States / Seemedx, Inc
Seemedx, Inc: FDA-registered device maker in Las Vegas, NV, United States, 6 510(k) clearances
Seemedx, Inc is registered with the FDA (registration 3021242837) in Las Vegas, NV, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 22, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021242837
- Address
- 6280 S Valley View Blvd. Suite 632, Las Vegas, NV, United States, 89118
- Owner or operator
- Seemedx, Inc (10083858)
- Roles
- Specification developer
- First device listed
- December 23, 2021
- Registered through
- 2026
- Brand names listed
- IQ System, ZOE Fluid Status Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Pre-Programmed, Single-Function | DXG | 2 | Specification developer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | 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 |
|---|---|---|---|---|---|---|
| January 22, 2014 | K133301 | ZOE FLUID STATUS MONITOR | DSB | Substantially Equivalent | Noninvasive Medical Technologies, Inc. | accessdata.fda.gov |
| June 28, 2013 | K131509 | ZOE FLUID STATUS MONITOR | DSB | Substantially Equivalent | Noninvasive Medical Technologies, Inc. | accessdata.fda.gov |
| November 13, 2012 | K112830 | ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) | DSB | Substantially Equivalent | Noninvasive Medical Technologies, Inc. | accessdata.fda.gov |
| September 14, 2004 | K042113 | ZOE FLUID STATUS MONITOR | DSB | Substantially Equivalent | Noninvasive Medical Technologies, LLC | accessdata.fda.gov |
| February 8, 1999 | K981720 | IQ SYSTEM | DSB | Substantially Equivalent | Renaissance Technology, Inc. | accessdata.fda.gov |
| December 8, 1992 | K922218 | IQ SYSTEM | DXG | Substantially Equivalent | Renaissance Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Plethysmograph, Impedance
- All makers of Computer, Diagnostic, Pre-Programmed, Single-Function
Updated January 22, 2014. 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.