FDA.reportPublic FDA data

Doppler Fetal Heart Rate Detector

Primary DI
06937683443128
Brand
Doppler Fetal Heart Rate Detector
Company
Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Model
FM-200
Published
2016-10-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNGMonitor, Ultrasonic, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNGMonitor, Ultrasonic, FetalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100626000DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200Shenzhen Biocare Electronics Co., Ltd.2010-05-21KNG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06937683490009PackageGS11In Commercial Distribution
06937683443128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06937683490009069376834900096937683490009
06937683443128069376834431286937683443128

GMDN Terms#

Term, Definition table
TermDefinition
Foetal Doppler systemA portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529081176
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06937683402019Digital ElectrocardiographECG-20002016-12-16
06937683413855Digital ElectrocardiographiE102018-01-30
06937683411448Digital ElectrocardiographiE1012016-10-18
06937683411530Digital ElectrocardiographiE 12A2016-10-18
06937683412346Digital ElectrocardiographiE32016-10-18
06937683412377Digital ElectrocardiographiE3002016-10-18
06937683412520Digital ElectrocardiographECG-30102016-10-18
06937683413022Digital ElectrocardiographiE122016-10-18
06937683413329Digital ElectrocardiographECG-12102016-10-18
06937683414319Digital ElectrocardiographiE62016-10-18
06937683415125Digital ElectrocardiographiE152016-10-18
06937683413879Digital ElectrocardiographiE102018-01-30
06937683490092Digital ElectrocardiographECG-20002016-12-16

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Primary DI, Brand, Company table
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00850067960034Imex 3MHZ DOPPLER PROBE,PD2IMEX, LLCKNG2026-05-18
00850067960058Imex DOPPLER PROBE, 2MHZ, H2O PROOF PDIIIMEX, LLCKNG2026-05-18
00850067960041Imex 2MHZ Doppler Probe PD2IMEX, LLCKNG2026-05-13
00860011754510Imex Pocket Dop II Doppler SystemIMEX, LLCKNG2026-05-13
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