Device Classification Name |
electromyograph, diagnostic
|
510(k) Number |
K172743 |
Device Name |
Natus VikingQuest |
Applicant |
Natus Neurology Incorporated |
3150 Pleasant View Road |
Middleteon,
WI
53562
|
|
Applicant Contact |
Shane T. Sawall |
Correspondent |
Natus Neurology Incorporated |
3150 Pleasant View Road |
Middleteon,
WI
53562
|
|
Correspondent Contact |
Shane T. Sawall |
Regulation Number | 890.1375
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/12/2017 |
Decision Date | 12/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|