510(k) DEN180024

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

March 28, 2019

Date Received

April 27, 2018

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Diagnostic Neurosurgical Microscope Filter

Device Class

Class II

Regulation Number

882.4950

Review Panel

NE

Submission Type

A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.