Cleared Traditional

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

K935757 · Greenleaf Medical Systems, Inc. · Neurology

Apr 1994

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K935757 is an FDA 510(k) clearance for the GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM, a Dynamometer, Ac-powered (Class II — Special Controls, product code LBB), submitted by Greenleaf Medical Systems, Inc. (Palo Alto, US). The FDA issued a Cleared decision on April 15, 1994, 140 days after receiving the submission on November 26, 1993. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1240.

Submission Details

510(k) Number	K935757 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 26, 1993
Decision Date	April 15, 1994
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement