Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device |
510(K) Number |
K181207 |
Device Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter |
Applicant |
Everyway Medical Instruments CO., LDT.
3 Fl., No. 5, Lane 155, Sec.3 Beishen Rd.
New Taipei City 22203 TW
Other 510(k) Applications for this Company
|
Contact |
Paul Hung
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 |
05/07/2018 |
Decision Date |
06/06/2018 |
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 |
|