Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K163393
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K163393
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
Hi-Dow International, Inc.
2555 Metro Blvd
Maryland Heights, MO 63043 US
Other 510(k) Applications for this Company
Contact
Eric Chen
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/02/2016
Decision Date
08/04/2017
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