Cleared Traditional

AMX-110, AMX-II AND AMX-III

K884340 · Dyna-Med · Radiology
Jan 1989
Decision
102d
Days
Class 1
Risk

About This 510(k) Submission

K884340 is an FDA 510(k) clearance for the AMX-110, AMX-II AND AMX-III, a Accessories, Traction (Class I — General Controls, product code ILZ), submitted by Dyna-Med (Victoria, US). The FDA issued a Cleared decision on January 24, 1989, 102 days after receiving the submission on October 14, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 890.5925.

Submission Details

510(k) Number K884340 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1988
Decision Date January 24, 1989
Days to Decision 102 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code ILZ — Accessories, Traction
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5925