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510(k) K222327

Device
Bloomlife MFM-Pro
Applicant
Bloom Technologies NV
510(k) number
K222327
Product code
HGM
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-13
Date received
2022-08-02
Regulation
884.2740
Classification name
System, Monitoring, Perinatal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Roberto Cunha
Address
Schiepse Bos 6 Genk BE 3600 3600

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HGM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253021ANNE MaternalSibel Health, Inc.2026-02-26
K250777Sonicaid Team3Huntleigh Healthcare , Ltd.2025-09-19
K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.2025-08-27
K241368Sonicaid Team3Huntleigh Healthcare , Ltd.2025-02-03
K241009PeriCALM Patterns 3.0Perigen, Inc.2025-01-10
K233440Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)Philips Medizin Systeme Boeblingen GmbH2024-07-02
K231964Novii+ Wireless Patch SystemDatex Ohmeda2023-12-08
K220732Mural Perinatal SurveillanceGe Medical Systems Information Technologies, Inc.2022-06-23
K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited2020-06-24
K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH2018-09-10
K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc.2018-08-30
K173715AlertWatch:OBAlertwatch, Inc.2018-04-23
K171178Central Monitoring SystemEdan Instruments, Inc.2017-09-06
K171865F1 Mothership Wireless Transducers for Fetal Ultrasonic and Tocodynamometer MonitoringFarus, LLC2017-08-24
K161902Meridian M110 Fetal Monitoring SystemMindchild Medical2017-01-12