FDA.report

510(k) K243982

Device
Nicolet EDX
Applicant
Natus Neurology Incorporated
510(k) number
K243982
Product code
GWF
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-22
Date received
2024-12-23
Regulation
882.1870
Classification name
Stimulator, Electrical, Evoked Response
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Judy Samson
Address
3150 Pleasant View Rd. Middleton WI US 53562 53562

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

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K182542The EPAD 2 SystemSafeop Surgical, Inc.2019-02-22
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K162873MEP MonitorTonica Elektronik A/S2017-03-31