Cleared Traditional

STEALTHSTATION TREATMENT GUIDANCE PLAFFORM

K983397 · Surgical Navigation Technologies, Inc. · Neurology

Dec 1998

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K983397 is an FDA 510(k) clearance for the STEALTHSTATION TREATMENT GUIDANCE PLAFFORM, 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 December 4, 1998, 70 days after receiving the submission on September 25, 1998. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K983397 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 1998
Decision Date	December 04, 1998
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF