Cleared Traditional

STEALTHSTATION SYSTEM

K983670 · Surgical Navigation Technologies, Inc. · Neurology
Jan 1999
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K983670 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 14, 1999, 87 days after receiving the submission on October 19, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K983670 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1998
Decision Date January 14, 1999
Days to Decision 87 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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