Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K163150
Device Classification Name
Electromyograph, Diagnostic
More FDA Info for this Device
510(K) Number
K163150
Device Name
Electromyograph, Diagnostic
Applicant
DORSAVI LTD
LEVEL 1, 120 JOLIMONT RD
EAST MELBOURNE 3002 AU
Other 510(k) Applications for this Company
Contact
DAN RONCHI
Other 510(k) Applications for this Contact
Regulation Number
890.1375
More FDA Info for this Regulation Number
Classification Product Code
IKN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2016
Decision Date
07/14/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
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