Cleared Traditional

K951341 - NEITZ SLIT LAMP SL-H2
(FDA 510(k) Clearance)

K951341 · Neitz Instruments Company, Ltd. · Ophthalmic

Jun 1995

Decision

83d

Days

Class 2

Risk

K951341 is an FDA 510(k) clearance for the NEITZ SLIT LAMP SL-H2. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO).

Submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on June 15, 1995, 83 days after receiving the submission on March 24, 1995.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number	K951341 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 1995
Decision Date	June 15, 1995
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement