Device Classification Name |
Transcranial Magnetic Stimulator
|
510(k) Number |
K212723 |
Device Name |
BTL-995-rTMS |
Applicant |
BTL Industries Inc. |
362 Elm Street |
Marlborough,
MA
01752
|
|
Applicant Contact |
David Chmel |
Correspondent |
BTL Industries Inc. |
362 Elm Street |
Marlborough,
MA
01752
|
|
Correspondent Contact |
David Chmel |
Regulation Number | 882.5805
|
Classification Product Code |
|
Date Received | 08/27/2021 |
Decision Date | 03/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|