Cleared Traditional

HEINE LAMBDA 100

K944156 · Heine USA , Ltd. · Ophthalmic

Jan 1995

Decision

139d

Days

Class 1

Risk

About This 510(k) Submission

K944156 is an FDA 510(k) clearance for the HEINE LAMBDA 100, a Chart, Visual Acuity (Class I — General Controls, product code HOX), submitted by Heine USA , Ltd. (Cary, US). The FDA issued a Cleared decision on January 12, 1995, 139 days after receiving the submission on August 26, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1150.

Submission Details

510(k) Number	K944156 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 1994
Decision Date	January 12, 1995
Days to Decision	139 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement