Cleared Traditional

STEALTHSTATION TREATMENT GUIDANCE PLATFORM

K981768 · Surgical Navigation Technologies, Inc. · Neurology
Nov 1998
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K981768 is an FDA 510(k) clearance for the STEALTHSTATION TREATMENT GUIDANCE PLATFORM, 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 November 23, 1998, 188 days after receiving the submission on May 19, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K981768 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1998
Decision Date November 23, 1998
Days to Decision 188 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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