Device Classification Name |
External Upper Limb Tremor Stimulator
|
510(k) Number |
K182706 |
Device Name |
External upper limb tremor stimulator |
Applicant |
Cala Health, Inc. |
875 Mahler Road, Suite 168 |
Burlingame,
CA
94010
|
|
Applicant Contact |
Scott A. Wilson |
Correspondent |
Cala Health, Inc. |
875 Mahler Road, Suite 168 |
Burlingame,
CA
94010
|
|
Correspondent Contact |
Scott A. Wilson |
Regulation Number | 882.5897
|
Classification Product Code |
|
Date Received | 09/27/2018 |
Decision Date | 10/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|