Device Classification Name |
transmitters and receivers, physiological signal, radiofrequency
|
510(k) Number |
K212883 |
Device Name |
ers2 - ergoline Rehabilitation System |
Applicant |
ergoline GmbH |
Lindenstrasse 5 |
Bitz,
DE
72475
|
|
Applicant Contact |
Alexandra Lertz |
Correspondent |
ergoline GmbH |
Lindenstrasse 5 |
Bitz,
DE
72475
|
|
Correspondent Contact |
Alexandra Lertz |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 09/10/2021 |
Decision Date | 07/15/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|