FDA.report

510(k) K242345

Device
Delphi Stimulator
Applicant
Quantalx Neuroscience
510(k) number
K242345
Product code
GWF
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-05
Date received
2024-08-07
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
Iftach Dolev
Address
1 Hatachana St. Kfar Sava IL 4453001 4453001

FDA Registration Numbers

Source Documents

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

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