Device Classification Name |
amplitude-integrated electroencephalograph
|
510(k) Number |
K152301 |
Device Name |
Background Pattern Classification [BPc(TM)] |
Applicant |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
2568 Bristol Circle |
Oakville,
CA
L6H5S1
|
|
Applicant Contact |
Sanjay Mehta |
Correspondent |
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) |
2568 Bristol Circle |
Oakville,
CA
L6H5S1
|
|
Correspondent Contact |
Sanjay Mehta |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/14/2015 |
Decision Date | 06/03/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|