FDA.report

510(k) K234080

Device
MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
Applicant
Soterix Medical, Inc.
510(k) number
K234080
Product code
GWF
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-25
Date received
2023-12-22
Regulation
882.1870
Classification name
Stimulator, Electrical, Evoked Response
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Danielle Dadona
Address
1480 Us Hwy. 9n Suite 204 Woodbridge NJ US 07095 07095

FDA Registration Numbers

Source Documents

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

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