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FDA 510(k)

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring

K-Number: K171865 · 2017-08-24

ApplicantFarus, LLC
Decision Date2017-08-24
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a medical device manufactured by Farus, LLC. It received FDA 510(k) clearance on 2017-08-24 under approval number K171865. 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 F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring?

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is a medical device that received FDA 510(k) clearance on 2017-08-24. It is manufactured by Farus, LLC. The 510(k) number is K171865.

When was F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring approved by the FDA?

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring received FDA 510(k) clearance on 2017-08-24, under approval number K171865.

What company makes F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring?

F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is manufactured by Farus, LLC.

What is the FDA product code for F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring?

The FDA product code for F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer Monitoring is HGM.

Related Clinical Trials

NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants NOT_YET_RECRUITING 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 NCT04956354 The Use of Wireless Sensors in Neonatal Intensive Care ACTIVE_NOT_RECRUITING

Related Devices (Code: HGM)

K153580Central Monitoring SystemGuangdong Biolight Meditech Co., Ltd. K171178Central Monitoring SystemEdan Instruments, Inc. 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. K173715AlertWatch:OBAlertwatch, 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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