Device Classification Name |
Electrode, Needle, Diagnostic Electromyograph
|
510(k) Number |
K161430 |
Device Name |
Myoject Luer Lock Needle Electrode |
Applicant |
Natus Manufacturing Limited |
IDA Business Park |
Gort,
IE
|
|
Applicant Contact |
Michael Galvin |
Correspondent |
Natus Manufacturing Limited |
IDA Business Park |
Gort,
IE
|
|
Correspondent Contact |
Michael Galvin |
Regulation Number | 890.1385
|
Classification Product Code |
|
Date Received | 05/23/2016 |
Decision Date | 03/02/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|