The following data is part of a premarket notification filed by Hipposcreen Neurotech Corp. with the FDA for 8-ch Electroencephalography Amplifier.
| Device ID | K201747 |
| 510k Number | K201747 |
| Device Name: | 8-CH Electroencephalography Amplifier |
| Classification | Amplifier, Physiological Signal |
| Applicant | HippoScreen Neurotech Corp. 2F., No. 578, Ruiguang Rd., Neihu District Taipei City, TW 11492 |
| Contact | William Lan |
| Correspondent | William Lan HippoScreen Neurotech Corp. 2F., No. 578, Ruiguang Rd., Neihu District Taipei City, TW 11492 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-26 |
| Decision Date | 2020-12-27 |