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FDA 510(k)

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)

K-Number: K233440 · 2024-07-02

ApplicantPhilips Medizin Systeme Boeblingen GmbH
Decision Date2024-07-02
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) is a medical device manufactured by Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2024-07-02 under approval number K233440. 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 Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)?

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) is a medical device that received FDA 510(k) clearance on 2024-07-02. It is manufactured by Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K233440.

When was Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) approved by the FDA?

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) received FDA 510(k) clearance on 2024-07-02, under approval number K233440.

What company makes Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)?

Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) is manufactured by Philips Medizin Systeme Boeblingen GmbH.

What is the FDA product code for Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)?

The FDA product code for Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) 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 Philips Medizin Systeme Boeblingen GmbH

K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800 K172904IntelliVue Capnography Extension, IntelliVue Microstream Extension K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable K161767Philips IntelliVue GuardianSoftware K181831IntelliVue Multi-Measurement Module MMX K173941IntelliSpace Perinatal Rev.K.00

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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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