Device Classification Name |
Magnetoencephalograph
|
510(k) Number |
K152184 |
Device Name |
MagView BIOMAGNETOMETER SYSTEM |
Applicant |
TRISTAN TECHNOLOGIES, INC |
6191 CORNERSTONE CT., STE 107 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
KEVIN PRATT |
Correspondent |
EUGENE HIRSCHKOFF, CONSULTANT |
3365 CALLE MARGARITA |
ENCINITAS,
CA
92024
|
|
Correspondent Contact |
EUGENE HIRSCHKOFF |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 08/05/2015 |
Decision Date | 04/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|