Device Classification Name |
Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
|
510(k) Number |
K140094 |
Device Name |
SPRINGTMS TOTAL MIGRAINE SYSTEM |
Applicant |
ENEURA THERAPEUTICS, LLC |
2690 PHEASANT ROAD |
ORONO,
MN
55331
|
|
Applicant Contact |
LARRY GETLIN |
Correspondent |
ENEURA THERAPEUTICS, LLC |
2690 PHEASANT ROAD |
ORONO,
MN
55331
|
|
Correspondent Contact |
LARRY GETLIN |
Regulation Number | 882.5808
|
Classification Product Code |
|
Date Received | 01/14/2014 |
Decision Date | 05/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|