Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K180421
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K180421
Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant
Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville L6H 5SI CA
Other 510(k) Applications for this Company
Contact
Shane Sawall
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OMB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/16/2018
Decision Date
03/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact