Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K170564
Device Classification Name
Stimulator, Neuromuscular, External Functional
More FDA Info for this Device
510(K) Number
K170564
Device Name
Stimulator, Neuromuscular, External Functional
Applicant
MyndTec Inc
2233 Argentia Road
Suite 307
Mississauga l5n 2x7 CA
Other 510(k) Applications for this Company
Contact
Alexa Granger
Other 510(k) Applications for this Contact
Regulation Number
882.5810
More FDA Info for this Regulation Number
Classification Product Code
GZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/27/2017
Decision Date
08/30/2017
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