510(k) DEN210003

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

August 23, 2021

Date Received

February 3, 2021

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Brain Stimulation Programming Planning Software.

Device Class

Class II

Regulation Number

882.5855

Review Panel

NE

Submission Type

The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.