Cleared Traditional

K993673 - SNN FLUORO NAVIGATION SYSTEM
(FDA 510(k) Clearance)

K993673 · I.S.G. Technologies, Inc. · Neurology

Dec 1999

Decision

50d

Days

Class 2

Risk

K993673 is an FDA 510(k) clearance for the SNN FLUORO NAVIGATION SYSTEM, 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 December 21, 1999, 50 days after receiving the submission on November 1, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K993673 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 01, 1999
Decision Date	December 21, 1999
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF