Device Classification Name |
reduced- montage standard electroencephalograph
|
510(k) Number |
K203827 |
Device Name |
REMI |
Applicant |
Epitel, Inc. |
124 S. 400 E. |
Salt Lake City,
UT
84111
|
|
Applicant Contact |
Mark Lehmkuhle |
Correspondent |
LeanRAQA |
12602 North Summerwind Drive |
Marana,
AZ
85658
|
|
Correspondent Contact |
John Pappan |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/29/2020 |
Decision Date | 03/29/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|