FDA.reportPublic FDA data

FC1400

Primary DI
08809276943606
Brand
FC1400
Company
Bionet CO,LTD
Model
FC1400
Device description
SYSTEM, MONITORING, PERINATAL
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
K043598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043598000FC 1400 FETAL MONITORBionet Co., Ltd.2005-12-16HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809276943603PackageGS14In Commercial Distribution
08809276943606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880927694360318809276943603
08809276943606088092769436068809276943606

GMDN Terms#

Term, Definition table
TermDefinition
Foetal cardiac monitorA mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by: 1) electronically registering and graphically presenting foetal heart sounds; 2) discriminating foetal and maternal electrocardiographic signals obtained from the maternal abdomen with external electrodes; or 3) transmitting and receiving ultrasonic energy into and from the pregnant woman usually by means of continuous wave (Doppler) echoscopy. The device may include an alarm that signals when the heart rate crosses a pre-set threshold.

Regulatory Flags#

DUNS number
689708212
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809276943958Cardio Q50, Cardio Q70Cardio Q502026-05-26
08809276943965Cardio Q50, Cardio Q70Cardio Q702026-05-26
08809276943972Cardio P1Cardio P12026-05-26
08809276944269Cardio Q50, Cardio Q70CardioExpress 40122026-05-26
08809276944276Cardio Q50, Cardio Q70CardioExpress 50122026-05-26
08809276943552Cardio7Cardio72021-07-15
08809276943729Spiro HandleSpiro Handle2021-07-15
08809276940285CardioXPCardioXP2021-07-15
08809276943538CardioCare2000CardioCare20002021-07-15
08809276943545CardioTouch3000CardioTouch30002021-07-15
08809276943590FC700FC7002021-07-15
08809276943644BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276940282CardioXPCardioXP2021-07-15
18809276943535CardioCare2000CardioCare20002021-07-15
18809276943542CardioTouch3000CardioTouch30002021-07-15
18809276943559Cardio7Cardio72021-07-15
18809276943597FC700FC7002021-07-15
18809276943603FC1400FC14002021-07-15
18809276943641BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276943726Spiro HandleSpiro Handle2021-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B153300010AirStrip ONE PlatformAirstrip Technologies, Inc.HGM2026-03-18
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
05051968048295OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048301OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048318OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048325OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048332OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048349OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048356OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048363OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048370OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048387OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048394OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048400OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048417OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048424OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
05051968048431OBIXHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
06944413814714Trolley(For medical use)Edan Instruments, Inc.HGM2025-12-09
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