Cleared Traditional

NON STRESS TEST MONITOR 507

K840285 · Imex Medical Systems, Inc. · Obstetrics & Gynecology
May 1984
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K840285 is an FDA 510(k) clearance for the NON STRESS TEST MONITOR 507, a Cannula, Suction, Uterine (Class II — Special Controls, product code HGH), submitted by Imex Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984, 106 days after receiving the submission on January 24, 1984. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5070.

Submission Details

510(k) Number K840285 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 1984
Decision Date May 09, 1984
Days to Decision 106 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HGH — Cannula, Suction, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5070