STEALTHSTATION

K954276 · Surgical Navigation Technologies, Inc. · HAW · Jan 24, 1996 · Neurology

Device Facts

Record IDK954276
Device NameSTEALTHSTATION
ApplicantSurgical Navigation Technologies, Inc.
Product CodeHAW · Neurology
Decision DateJan 24, 1996
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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