Cleared Traditional

K884611 - THE ORTHORANGER II ELECTRONIC GONIOMETER
(FDA 510(k) Clearance)

K884611 · Medical Instruments Technology, Inc. · Neurology device

Jan 1989

Decision

88d

Days

Class 1

Risk

K884611 is an FDA 510(k) clearance for the THE ORTHORANGER II ELECTRONIC GONIOMETER. This device is classified as a Goniometer, Ac-powered (Class I - General Controls, product code KQX).

Submitted by Medical Instruments Technology, Inc. (Alexandria, US). The FDA issued a Cleared decision on January 31, 1989, 88 days after receiving the submission on November 4, 1988.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.

Submission Details

510(k) Number	K884611 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 04, 1988
Decision Date	January 31, 1989
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—