Device Classification Name |
Amplifier, Physiological Signal
|
510(k) Number |
K201747 |
Device Name |
8-CH Electroencephalography Amplifier |
Applicant |
HippoScreen Neurotech Corp. |
2F., No. 578, Ruiguang Rd., Neihu District |
Taipei City,
TW
11492
|
|
Applicant Contact |
William Lan |
Correspondent |
HippoScreen Neurotech Corp. |
2F., No. 578, Ruiguang Rd., Neihu District |
Taipei City,
TW
11492
|
|
Correspondent Contact |
William Lan |
Regulation Number | 882.1835
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/26/2020 |
Decision Date | 12/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|