Cleared Traditional

INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE

K971079 · Interlogics, Inc. · Neurology

Jul 1997

Decision

106d

Days

Class 1

Risk

About This 510(k) Submission

K971079 is an FDA 510(k) clearance for the INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE, a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by Interlogics, Inc. (Hillsborough, US). The FDA issued a Cleared decision on July 9, 1997, 106 days after receiving the submission on March 25, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K971079 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 25, 1997
Decision Date	July 09, 1997
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement