FDA.report

510(k) K230415

Device
Cadwell Guardian
Applicant
Cadwell Industries, Inc.
510(k) number
K230415
Product code
GWF
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-17
Date received
2023-02-16
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
Jason Ford
Address
909 N Kellogg St. Kennewick WA US 99336 99336

FDA Registration Numbers

Source Documents

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

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