Cleared Traditional

DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)

K943929 · Greenleaf Medical Systems, Inc. · Neurology

May 1995

Decision

276d

Days

Class 1

Risk

About This 510(k) Submission

K943929 is an FDA 510(k) clearance for the DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS), a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by Greenleaf Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on May 15, 1995, 276 days after receiving the submission on August 12, 1994. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K943929 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1994
Decision Date	May 15, 1995
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement