Device Classification Name |
Non-Normalizing Quantitative Electroencephalograph Software
|
510(k) Number |
K190760 |
Device Name |
Cadwell Bolt Software |
Applicant |
Cadwell Industries, Inc. |
909 N. Kellogg Street |
Kennewick,
WA
99336
|
|
Applicant Contact |
Emily Whitehead |
Correspondent |
Cadwell Industries, Inc. |
909 N. Kellogg Street |
Kennewick,
WA
99336
|
|
Correspondent Contact |
Emily Whitehead |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/25/2019 |
Decision Date | 11/23/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|