Cleared Traditional

STREAK RETINOSCOPE RX-1

K950789 · Neitz Instruments Company, Ltd. · Ophthalmic

Mar 1995

Decision

35d

Days

Class 2

Risk

About This 510(k) Submission

K950789 is an FDA 510(k) clearance for the STREAK RETINOSCOPE RX-1, a Retinoscope, Ac-powered (Class II — Special Controls, product code HKL), submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on March 28, 1995, 35 days after receiving the submission on February 21, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1780.

Submission Details

510(k) Number	K950789 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 21, 1995
Decision Date	March 28, 1995
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement