System, Monitoring, Perinatal

Product Code: HGM

Obstetrics/Gynecology Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.2740


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HGM

3953System, Monitoring, PerinatalPerinatal Monitoring System And Accessories.

Total Product Life Cycle (TPLC) Devices

3953System, Monitoring, PerinatalPerinatal Monitoring System And Accessories.

Pre-market Notifications for HGM

K220732Mural Perinatal SurveillanceGE Medical Systems Information Technologies, Inc.
K200975Sonicaid Team3 Antepartum, Sonicaid Team3 IntrapartumHuntleigh Healthcare Limited
K173941IntelliSpace Perinatal Rev.K.00Philips Medizin Systeme Boeblingen GmbH
K173715AlertWatch:OBAlertWatch, Inc.
K173042Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3Edan Instruments, Inc
K171865F1 Mothership Wireless Transducers For Fetal Ultrasonic And Tocodynamometer MonitoringFarus, LLC
K171178Central Monitoring SystemEdan Instruments, Inc.
K161902Meridian M110 Fetal Monitoring SystemMINDCHILD MEDICAL
K153580Central Monitoring SystemGUANGDONG BIOLIGHT MEDITECH CO., LTD.
K150901Fetal & Maternal Monitor, Models F6, F6 Express, F9, F9 ExpressEDAN INSTRUMENTS, INC.
K150398EUM 100ProOB TOOLS, LTD.
K143695CENTRAL MONITORING SYSTEMEDAN INSTRUMENTS INC
K142883MindChild Meridian M100 Fetal Heart Rate MonitorMindchild Medical
K142799Model BT-220L And BT-220CBistos Co., Ltd.
K141194FM-3000 FETAL MONITORADVANCED INSTRUMENTATIONS, INC.

Global Unique Device Identification Database

00382830028554System, Monitoring, Perinatal
00382830028547System, Monitoring, Perinatal
00382830028530System, Monitoring, Perinatal
00382830028141System, Monitoring, Perinatal
00382830028134System, Monitoring, Perinatal
00382830028127System, Monitoring, Perinatal
00382830027892System, Monitoring, Perinatal
00382830027885System, Monitoring, Perinatal
00815871020282System, Monitoring, Perinatal
00815871020275System, Monitoring, Perinatal
00815871020268System, Monitoring, Perinatal
00815871020251System, Monitoring, Perinatal
00815871020244System, Monitoring, Perinatal
00815871020237System, Monitoring, Perinatal
00815871020220System, Monitoring, Perinatal

Maude Adverse Events

AVALON CL TOCO + MP TRANSDUCER (AS ON DOC)PHILIPS MEDICAL SYSTEMS2020-03-04
PHILIPS AVALON CTS CORDLESS FETAL TRANSDUCER SYSTEMPHILIPS MEDICAL SYSTEMS, INC.2020-02-28
AVALON FM50 FETAL MONITORPHILIPS MEDICAL SYSTEMS2020-01-30
PHILIPS AVALON FM20 FETAL MONITORPHILIPS MEDICAL SYSTEMS, INC.2020-01-22
ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALONPHILIPS MEDICAL SYSTEMS2020-01-10
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-14
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M2735A SMART TOCO + TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M2735A SMART TOCO + TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M2735A SMART TOCO + TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M1356A US BELT/WIRE KNOBPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M1356A US BELT/WIRE KNOBPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-11
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-08
AVALON FM50 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-11-08
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-11-07
AVALON FM20 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-10-30
PHILIPS M2734B SMART TOCO TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-29
PHILIPS M2734B SMART TOCO TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-29
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-21
PHILIPS M2734B SMART TOCO TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-20
PHILIPS M2735A SMART TOCO + TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-20
GE COROMETRICS 259CX FETAL MONITORGE HEALTHCARE2019-10-18
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-18
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-18
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-18
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-18
PHILIPS M2736A AVALON U/S TRANSDUCERPHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH2019-10-10
GE COROMETRICS NAUTILUS 2264HAX TOCO TRANSDUCER WITH KNOBGE HEALTHCARE2019-10-03
AVALON FM50 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-09-06
AVALON FM20 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-07-16
AVALON FM50 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-07-15
OBTV REV G ADVANCED SYSTEM SW ONLYPHILIPS MEDICAL SYSTEMS2019-07-12
PHILIPS M2725A WIRELESS TOCO TRANSDUCERPHILIPS MEDICAL SYSTEMS, INC.2019-07-09
GE COROMETRICS NAUTILUS 2264LAX TOCO TRANSDUCER WITH WINGGE HEALTHCARE2019-07-09
AVALON FM30 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-06-07
259CX CTG MONITORWIPRO GE HEALTHCARE PRIVATE LTD.2019-04-22
FETAL MONITOR SERIES 50 IPPHILIPS MEDICAL SYSTEMS2019-03-21
FETAL MONITOR SERIES 50 IPPHILIPS MEDICAL SYSTEMS2019-03-21
AVALON FM30 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-02-12
SONOLINE B (FETAL DOPPLER)BABY DOPPLER / DAGAMMA INC.2019-01-17
AVALON FM20 FETAL MONITORPHILIPS MEDICAL SYSTEMS2019-01-03
AVALON FM30 FETAL MONITORPHILIPS MEDICAL SYSTEMS2018-12-27
AVALON FM30 FETAL MONITORPHILIPS MEDICAL SYSTEMS2018-12-14
MONICA HEALTHCARE FETAL MONITORMONICA HEALTHCARE LTD.2018-12-05
MONICA FETAL MONITORING SYSTEMMONICA HEALTHCARE LTD.2018-12-05
ULTRASOUND TRANSDUCER FOR USE WITH FM20/FM30 AVALONPHILIPS MEDICAL SYSTEMS2018-11-02
CORO 172WIPRO GE HEALTHCARE PRIVATE LTD.2018-10-16
COROMETRICS 250CX SERIESWIPRO GE HEALTHCARE PRIVATE LIMITED2018-10-12
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