Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K182180
Device Classification Name
More FDA Info for this Device
510(K) Number
K182180
Device Name
SPEAC System
Applicant
Brain Sentinel, Inc.
8023 Vantage Dr., Suite 216
San Antonio, TX 78230 US
Other 510(k) Applications for this Company
Contact
Richard Waite
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
POS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/2018
Decision Date
05/11/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact