Cleared Traditional

SNT STEREOTACTIC LOCALIZATION SYSTEM

K971675 · Surgical Navigation Technologies, Inc. · Neurology
Jul 1997
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K971675 is an FDA 510(k) clearance for the SNT STEREOTACTIC LOCALIZATION 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 July 14, 1997, 68 days after receiving the submission on May 7, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K971675 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 1997
Decision Date July 14, 1997
Days to Decision 68 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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