Cleared Traditional

KOI BLUE FIELD ENTOPTOSCOPE

K812764 · Koi, Inc. · Ophthalmic

Dec 1981

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K812764 is an FDA 510(k) clearance for the KOI BLUE FIELD ENTOPTOSCOPE, a Retinoscope, Ac-powered (Class II — Special Controls, product code HKL), submitted by Koi, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1981, 61 days after receiving the submission on October 2, 1981. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1780.

Submission Details

510(k) Number	K812764 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 1981
Decision Date	December 02, 1981
Days to Decision	61 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—