FDA.report

510(k) K220122

Device
APEX 6
Applicant
Rf Innovations, Inc.
510(k) number
K220122
Product code
GXD
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-15
Date received
2022-01-18
Regulation
882.4400
Classification name
Generator, Lesion, Radiofrequency
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
William Rittman
Address
30 Log Bridge Rd. Middleton MA US 01949 01949

FDA Registration Numbers

Source Documents

510(k) summary PDF

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