Cleared Traditional

UTERINE SOUND

K840380 · Intl. Medical Technologies, Inc. · Obstetrics & Gynecology
Apr 1984
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K840380 is an FDA 510(k) clearance for the UTERINE SOUND, a Sound, Uterine (Class I — General Controls, product code HHM), submitted by Intl. Medical Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1984, 91 days after receiving the submission on January 30, 1984. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K840380 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1984
Decision Date April 30, 1984
Days to Decision 91 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