Cleared Traditional

STEALTHSTATION SYSTEM

K974187 · Surgical Navigation Technologies, Inc. · Neurology
Jan 1998
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K974187 is an FDA 510(k) clearance for the STEALTHSTATION SYSTEM, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on January 21, 1998, 131 days after receiving the submission on September 12, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K974187 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1997
Decision Date January 21, 1998
Days to Decision 131 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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