FDA.reportPublic FDA data

ADVANCED FETAL MONITOR

Primary DI
B510FM9000
Brand
ADVANCED FETAL MONITOR
Company
ADVANCED INSTRUMENTATIONS, INC.
Model
FM-9000
Published
2025-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112317000FM-9000 PLUS FETAL AND MATERNAL MONITORAdvanced Instrumentations, Inc.2011-12-21HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B510FM9000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Foetal/maternal prenatal monitorAn electrically-powered device designed for continuous monitoring of foetal heart activity and maternal uterine contractions during the prenatal (commonly perinatal) period; it may monitor additional maternal parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse oximetry (SpO2)]. Also known as a cardiotocograph, uterine contractions are acquired using a tocodynamometer (pressure transducer) strapped onto the mother's abdomen, while foetal heart rate is typically measured with a dedicated ultrasound transducer. The results may be displayed via print-out or electronically; telemetry features may also be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
608736880
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B510SL700700LED1ADVANCED SURGICAL LAMP SL700/700 LED2026-03-24
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM DUS-60002026-03-24
B510D100ADVANCED MONITOR DEFIBRILLATORD100+2026-01-14
B510PT3000ADVANCED PHOTOTHERAPY LAMP PT-30002025-08-21
B510PM200MPRO1ADVANCED PATIENT MONITORPM-200M PRO2025-07-23
B510V1000ADVANCED VENTILATORV-10002025-02-10
B510A31860ADVANCED NEONATAL INCUBATORA31862025-02-07
B510A31861ADVANCED NEONATAL INCUBATORA3186+2025-02-07
B510A4051ADVANCED INFANT WARMERA40512025-02-07
B510AM60001ADVANCED GAS-MACHINE ANESTHESIAAM-6000+2025-02-07
B510PT2000ADVANCED LED PHOTOTHERAPY LAMPPT-20002025-02-07
B510PT5000ADVANCED LED PHOTOTHERAPY LAMPPT-50002025-02-07
B510A3158ADVANCED TRANSPORT INCUBATORA31582025-02-04
B510IP200ADVANCED INFUSION PUMPIP-2002025-02-04
B510PMMAX13ADVANCED PATIENT MONITORPM-Max132024-12-19
B510PMMAX15ADVANCED PATIENT MONITORPM-Max152024-12-19
B510PM2000A1ADVANCED PATIENT MONITORPM-2000A2020-04-16
B510PM2000APRO1ADVANCED PATIENT MONITORPM-2000A PRO2020-04-16
B510PM2000M1ADVANCED PATIENT MONITORPM-2000M2020-04-16
B510PM2000XL1ADVANCED PATIENT MONITORPM-2000XL2020-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B153301010AirStrip ONE Client iOSAirstrip Technologies, Inc.HGM2026-03-18
B153301020AirStrip ONE Client AndroidAirstrip Technologies, Inc.HGM2026-03-18
05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048240SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048257SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048264SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048271SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048288SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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06944413819726Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413819733Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
06944413807112Remote Event MarkerEdan Instruments, Inc.HGM2025-11-29
00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21