The following data is part of a premarket notification filed by Natus Neurology Incorporated with the FDA for Natus Vikingquest.
Device ID | K172743 |
510k Number | K172743 |
Device Name: | Natus VikingQuest |
Classification | Electromyograph, Diagnostic |
Applicant | Natus Neurology Incorporated 3150 Pleasant View Road Middleteon, WI 53562 |
Contact | Shane T. Sawall |
Correspondent | Shane T. Sawall Natus Neurology Incorporated 3150 Pleasant View Road Middleteon, WI 53562 |
Product Code | IKN |
Subsequent Product Code | GWE |
Subsequent Product Code | GWF |
Subsequent Product Code | GWJ |
Subsequent Product Code | GZP |
Subsequent Product Code | JXE |
Subsequent Product Code | OLT |
CFR Regulation Number | 890.1375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-12 |
Decision Date | 2017-12-19 |
Summary: | summary |