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FDA 510(k)

Fetal & Maternal Monitor (F15A, F15A Air)

K-Number: K241882 · 2025-08-27

ApplicantEdan Instruments, Inc.
Decision Date2025-08-27
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal & Maternal Monitor (F15A, F15A Air) is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-08-27 under approval number K241882. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fetal & Maternal Monitor (F15A, F15A Air)?

Fetal & Maternal Monitor (F15A, F15A Air) is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K241882.

When was Fetal & Maternal Monitor (F15A, F15A Air) approved by the FDA?

Fetal & Maternal Monitor (F15A, F15A Air) received FDA 510(k) clearance on 2025-08-27, under approval number K241882.

What company makes Fetal & Maternal Monitor (F15A, F15A Air)?

Fetal & Maternal Monitor (F15A, F15A Air) is manufactured by Edan Instruments, Inc..

What is the FDA product code for Fetal & Maternal Monitor (F15A, F15A Air)?

The FDA product code for Fetal & Maternal Monitor (F15A, F15A Air) is HGM.

Related Clinical Trials

NCT07578597 The BAMBI II Study ENROLLING_BY_INVITATION NCT04542148 Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes ACTIVE_NOT_RECRUITING NCT06729827 Predictive Hemodynamic Monitoring During Elective Cesarean Section COMPLETED NCT07576881 Impact of Standardization on Outcomes Following Cervical Ripening NOT_YET_RECRUITING NCT06281717 Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia WITHDRAWN NCT05704257 Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial RECRUITING

Related PubMed Literature

PMID: 42086270 Abdominopelvic computed tomography during pregnancy and the risk of congenital malformations: protocol for a nationwide population-based cohort study in South Korea. BMJ open (2026)

Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K161300Acclarix AX8 Diagnostic Ultrasound System K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System

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Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171178Central Monitoring SystemEdan Instruments, Inc. K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC K161902Meridian M110 Fetal Monitoring SystemMindchild Medical K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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