Cleared Traditional

K951179 - DIGITAL RETINOSCOPIC PHOTOMETER
(FDA 510(k) Clearance)

K951179 · Kudi Kalu, Inc. · Ophthalmic

May 1995

Decision

75d

Days

Class 1

Risk

K951179 is an FDA 510(k) clearance for the DIGITAL RETINOSCOPIC PHOTOMETER. This device is classified as a Refractometer, Ophthalmic (Class I — General Controls, product code HKO).

Submitted by Kudi Kalu, Inc. (Huntsville, US). The FDA issued a Cleared decision on May 30, 1995, 75 days after receiving the submission on March 16, 1995.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number	K951179 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 16, 1995
Decision Date	May 30, 1995
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF