Cleared Traditional

GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM

K893537 · Greenleaf Medical Systems, Inc. · Neurology
Oct 1989
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K893537 is an FDA 510(k) clearance for the GREENLEAF HAND IMPAIRMENT EVALUATION SYSTEM, 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 October 10, 1989, 155 days after receiving the submission on May 8, 1989. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1240.

Submission Details

510(k) Number K893537 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1989
Decision Date October 10, 1989
Days to Decision 155 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code LBB — Dynamometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.1240

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