Cleared Traditional

ISG VIEWING WAND

K960714 · I.S.G. Technologies, Inc. · Neurology
May 1996
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K960714 is an FDA 510(k) clearance for the ISG VIEWING WAND, 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 May 29, 1996, 98 days after receiving the submission on February 21, 1996. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K960714 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1996
Decision Date May 29, 1996
Days to Decision 98 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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