Data / Medical devices / United States / HyperMed Technologies Corp.
HyperMed Technologies Corp.: FDA-registered device maker in Grand Forks, ND, United States, 1 510(k) clearance
HyperMed Technologies Corp. is registered with the FDA (registration 3042025620) in Grand Forks, ND, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3042025620
- Address
- 4200 James Ray Dr, Grand Forks, ND, United States, 58202
- Owner or operator
- SafetySpect (10094214)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 19, 2025
- Registered through
- 2027
- Brand names listed
- HyperView, SafetySpect MDDS System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Oximeter, Tissue Saturation | MUD | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| December 16, 2016 | K161237 | HyperView Hyperspectral Tissue Oxygenation Measurement System | MUD | Substantially Equivalent | Hypermed Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
Updated December 16, 2016. 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.