Device Classification Name |
Transcranial Magnetic Stimulator
|
510(k) Number |
K180313 |
Device Name |
Apollo TMS Therapy System |
Applicant |
Mag & More GmbH |
Machtlfinger Strasse l3 |
Munich,
DE
81379
|
|
Applicant Contact |
Kerstin Haringer |
Correspondent |
Mag & More GmbH |
Machtlfinger Strasse l3 |
Munich,
DE
81379
|
|
Correspondent Contact |
Kerstin Haringer |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 02/05/2018 |
Decision Date | 05/04/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|