Device Classification Name |
Stimulator, Spinal-Cord, Implanted (Pain Relief)
|
510(k) Number |
K203547 |
Device Name |
Nalu Neurostimulation System |
Applicant |
Nalu Medical, Inc. |
2320 Faraday Ave. Suite 100 |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Pauline Lieu |
Correspondent |
Nalu Medical, Inc. |
2320 Faraday Ave. Suite 100 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Pauline Lieu |
Regulation Number | 882.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/04/2020 |
Decision Date | 03/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|