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Model IM77 Intrapartum Fetal Monitor (Modification)

by Advanced Medical Systems, Inc.

510(k) K955931

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955931 Date14 Aug 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HGM
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model IM77 Intrapartum Fetal Monitor is a perinatal monitoring system designed to graphically display the relationship between maternal uterine contractions and fetal heart rate. It combines and coordinates uterine contraction and fetal heart monitors, providing real-time visual assessment of fetal well-being during labor and delivery.

This device is intended for use in obstetric settings and has received FDA 510(k) clearance under the classification of a Class II medical device (HGM product code). It is supplied as a reusable system and is regulated under the U.S. Food and Drug Administration’s 510(k) pathway, with a decision date of August 14, 1996. The monitor is intended for clinical use in monitoring fetal status during intrapartum periods.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Model IM77 Intrapartum Fetal Monitor in clinical settings?

    The Model IM77 Intrapartum Fetal Monitor is designed to visually display the relationship between maternal uterine contractions and fetal heart rate in real-time. This allows clinicians to assess fetal well-being during labor and delivery, helping to monitor the baby’s status continuously during the intrapartum period.

  • Is the Model IM77 Intrapartum Fetal Monitor intended for single-use or reusable applications?

    The Model IM77 Intrapartum Fetal Monitor is supplied as a reusable system. This means it is designed for repeated use across multiple patients, provided it is properly cleaned, maintained, and sterilized according to manufacturer guidelines.

  • What regulatory pathway was used for FDA clearance of this device, and when was the decision made?

    The Model IM77 Intrapartum Fetal Monitor received FDA clearance through the 510(k) pathway, specifically under the classification of a Class II medical device (HGM product code). The decision was made on August 14, 1996, and it was determined to be substantially equivalent to a predicate device.

  • What types of clinical environments is this device intended for?

    This device is intended exclusively for use in obstetric settings, where continuous monitoring of fetal heart rate and uterine contractions is critical during labor and delivery. It is not intended for use outside of these clinical environments.