Cleared Traditional

ORBSCAN(TM) KERATOMETER

K940647 · Orbtek, Inc. · Ophthalmic

Jul 1994

Decision

141d

Days

Class 1

Risk

About This 510(k) Submission

K940647 is an FDA 510(k) clearance for the ORBSCAN(TM) KERATOMETER, a Keratoscope, Ac-powered (Class I — General Controls, product code HLQ), submitted by Orbtek, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 6, 1994, 141 days after receiving the submission on February 15, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1350.

Submission Details

510(k) Number	K940647 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 1994
Decision Date	July 06, 1994
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF