Device Classification Name |
Stimulator, Nerve, Peripheral, Electric
|
510(k) Number |
K201949 |
Device Name |
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series |
Applicant |
Nihon Kohden Corporation |
1-31-4 Nishiochiai, Shinjuki-Ku |
Tokyo,
JP
161-8560
|
|
Applicant Contact |
Sandra Gadeyne |
Correspondent |
Nihon Kohden America, Inc. |
15353 Barranca Parkway |
Irvine,
CA
92618
|
|
Correspondent Contact |
Sunita Teekasingh |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 07/13/2020 |
Decision Date | 05/02/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|