Cleared Traditional

K924782 - BURTON SLIT LAMP - MODEL 2000 (FDA 510(k) Clearance)

K924782 · R.H. Burton Co. · Ophthalmic device

Jan 1993

Decision

126d

Days

Class 2

Risk

K924782 is an FDA 510(k) clearance for the BURTON SLIT LAMP - MODEL 2000. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).

Submitted by R.H. Burton Co. (Grove City, US). The FDA issued a Cleared decision on January 27, 1993, 126 days after receiving the submission on September 23, 1992.

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

Submission Details

510(k) Number	K924782 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 1992
Decision Date	January 27, 1993
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement