Cleared Traditional

AUGROS HYSTEROMETER

K831224 · Axcan Scientific Corp. · Obstetrics & Gynecology
Oct 1983
Decision
196d
Days
Class 1
Risk

About This 510(k) Submission

K831224 is an FDA 510(k) clearance for the AUGROS HYSTEROMETER, a Sound, Uterine (Class I — General Controls, product code HHM), submitted by Axcan Scientific Corp. (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983, 196 days after receiving the submission on April 15, 1983. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K831224 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1983
Decision Date October 28, 1983
Days to Decision 196 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHM — Sound, Uterine
Device Class Class I — General Controls
CFR Regulation 21 CFR 884.4530