MICROTARGETING DRIVE SYSTEM

K003776 · FHC, Inc. · HAW · Feb 23, 2001 · Neurology

Device Facts

Record IDK003776
Device NameMICROTARGETING DRIVE SYSTEM
ApplicantFHC, Inc.
Product CodeHAW · Neurology
Decision DateFeb 23, 2001
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 882.4560
Device ClassClass 2

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Innolitics

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