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STAN S31 Fetal Heart Monitor

by Neoventa Medical AB

PMA P020001

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P020001↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP020001 Date1 Nov 2005ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Analyzer, data, obstetric
PMA Number
FDA Product Code
HEO
Device Class
Class III
Regulation
21 CFR Part 884.2050
Advisory Committee
Obstetrics/Gynecology
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 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 STAN S31 Fetal Heart Monitor is an obstetric data analyzer indicated as an adjunct to fetal heart rate monitoring to determine whether obstetrical intervention is warranted when there is increased risk of developing metabolic acidosis. It is intended for use in patients with planned vaginal delivery, greater than 36 completed weeks gestation, singleton fetus, vertex presentation, and ruptured amniotic membranes.

The device is authorized under FDA PMA (P020001) and classified as a Class III obstetric data analyzer. It is manufactured by Neoventa Medical AB in Molndal, Sweden, and is intended for use in clinical settings during labor under the specified patient criteria.

Other devices from Neoventa Medical AB

Questions

AI-generated answers, 18 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 STAN S31 Fetal Heart Monitor used for?

    The STAN S31 Fetal Heart Monitor is used as an adjunct to fetal heart rate monitoring to help determine whether obstetrical intervention is warranted when there is an increased risk of developing metabolic acidosis in the fetus during labor.

  • Who manufactures the STAN S31 Fetal Heart Monitor?

    The STAN S31 Fetal Heart Monitor is manufactured by Neoventa Medical AB, located at Norra Agatan 32, Molndal, SE-431 35, Sweden.

  • What regulatory authorization does the STAN S31 Fetal Heart Monitor have?

    The STAN S31 Fetal Heart Monitor has received FDA Premarket Approval (PMA) under PMA number P020001, with approval granted on November 1, 2005.