FDA.reportPublic FDA data

ECG module

Primary DI
06971355420819
Brand
ECG module
Company
SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Model
ECG10
Device description
AHA
Published
2022-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYNSystem, Imaging, Pulsed Doppler, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210154000Labat series Diagnostic Ultrasound SystemShenzhen Wisonic Medical Technology Co. , Ltd.2021-07-30IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971355420819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971355420819069713554208196971355420819

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, electrocardiographicA small unit dedicated to the detection, measurement, and recording of the electrical activity of the heart in the form of an electrocardiogram (ECG) obtained through cables/leads connected to the patient. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the ECG parameter/information measured and provided by this module.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543063066
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971355421267Diagnostic Ultrasound SystemCarnation+ 2023-10-11
06971355421274Diagnostic Ultrasound SystemCarnation Exp2023-10-11
06971355421281Diagnostic Ultrasound SystemCarnation Neo2023-10-11
06971355421298Diagnostic Ultrasound SystemCarnation2023-10-11
06971355421304Diagnostic Ultrasound SystemCarnation T2023-10-11
06971355421311Diagnostic Ultrasound SystemCarnation Pro2023-10-11
06971355421328Diagnostic Ultrasound SystemCarnation Ultra2023-10-11
06971355421335Diagnostic Ultrasound SystemCarnation Fast2023-10-11
06971355421342Ultrasonic TransducerL8-3-H2023-10-11
06971355421359Ultrasonic TransducerP12-4-H2023-10-11
06971355420963Rechargeable Li-ion Battery PackLI14I06A-US882022-01-27
06971355420772Rechargeable Li-ion Battery PackLI14I13A2021-09-29
06971355420338WISONIC LI14I13A2019-12-19
06971355420321WISONIC LI14I06A2019-12-18
06971355420314Probe extenderTEM102022-01-27
06971355420826Magnetic cupMAG012022-01-27
06971355420833Magnetic cupMAG022022-01-27
06971355420840TEE Articulated ArmPHA-102022-01-27
06971355420857Barcode ReaderXenon 1900h2022-01-27
06971355420864Diagnostic Ultrasound SystemClivia 90Elite2022-01-27

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Primary DI, Brand, Company table
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