Cleared Traditional

O'BRIEN GONIOMETER

K926237 · Sgarlato Laboratories, Inc. · Neurology
Aug 1993
Decision
234d
Days
Class 1
Risk

About This 510(k) Submission

K926237 is an FDA 510(k) clearance for the O'BRIEN GONIOMETER, a Goniometer, Nonpowered (Class I — General Controls, product code KQW), submitted by Sgarlato Laboratories, Inc. (San Jose, US). The FDA issued a Cleared decision on August 2, 1993, 234 days after receiving the submission on December 11, 1992. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1520.

Submission Details

510(k) Number K926237 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1992
Decision Date August 02, 1993
Days to Decision 234 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

Product Code KQW — Goniometer, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.1520