Data / Medical devices / Taiwan / Hipposcreen Neurotech Corp.
Hipposcreen Neurotech Corp.: FDA-registered device maker in Neihu Dist. Taipei, Taiwan, 1 510(k) clearance
Hipposcreen Neurotech Corp. is registered with the FDA (registration 3038138206) in Neihu Dist. Taipei, Taiwan. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 27, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038138206
- Address
- 2F., No.578, Ruiguang Rd., Neihu Dist. Taipei, Taiwan, 114
- Owner or operator
- HippoScreen Neurotech Corp. (10093103)
- Roles
- Manufacturer
- First device listed
- March 31, 2025
- Registered through
- 2026
- Brand names listed
- 8-CH Electroencephalography Amplifier, HippoScreen Brain Degeneration Risk Assessment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Manufacturer | accessdata.fda.gov |
| Computerized Cognitive Assessment Aid, Exempt | PTY | 2 | Manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 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 27, 2020 | K201747 | 8-CH Electroencephalography Amplifier | GWL | Substantially Equivalent | Hipposcreen Neurotech Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Amplifier, Physiological Signal
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Computerized Cognitive Assessment Aid, Exempt
Updated December 27, 2020. 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.