Device Classification Name |
magnetoencephalograph
|
510(k) Number |
K133419 |
Device Name |
BABYMEG BIOMAGNETOMETER SYSTEM |
Applicant |
TRISTAN TECHNOLOGIES INC |
3365 CALLE MARGARITA |
ENCINITAS,
CA
92024
|
|
Applicant Contact |
EUGENE HIRSCHKOFF |
Correspondent |
TRISTAN TECHNOLOGIES INC |
3365 CALLE MARGARITA |
ENCINITAS,
CA
92024
|
|
Correspondent Contact |
EUGENE HIRSCHKOFF |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 11/07/2013 |
Decision Date | 07/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|