Cleared Traditional

SNN SCOUT

K982570 · I.S.G. Technologies, Inc. · Neurology
Jan 1999
Decision
174d
Days
Class 2
Risk

About This 510(k) Submission

K982570 is an FDA 510(k) clearance for the SNN SCOUT, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by I.S.G. Technologies, Inc. (Mississauga Ontario, CA). The FDA issued a Cleared decision on January 13, 1999, 174 days after receiving the submission on July 23, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K982570 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1998
Decision Date January 13, 1999
Days to Decision 174 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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