Cleared Traditional

ORTELIUS 800

K011827 · Orthoscan , Ltd. · Neurology

Aug 2001

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K011827 is an FDA 510(k) clearance for the ORTELIUS 800, a Goniometer, Ac-powered (Class I — General Controls, product code KQX), submitted by Orthoscan , Ltd. (Ra'Ananna, IL). The FDA issued a Cleared decision on August 28, 2001, 77 days after receiving the submission on June 12, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K011827 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2001
Decision Date	August 28, 2001
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF