Cleared Traditional

FINGER BONIOMETER BK7506

K831550 · Fred Sammons, Inc. · Neurology
Jun 1983
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K831550 is an FDA 510(k) clearance for the FINGER BONIOMETER BK7506, a Goniometer, Nonpowered (Class I — General Controls, product code KQW), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 43 days after receiving the submission on May 12, 1983. This device falls under the Neurology review panel. Regulated under 21 CFR 888.1520.

Submission Details

510(k) Number K831550 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 24, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

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