ECG module

GUDID 06971355420819

AHA

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

Patient monitoring system module, electrocardiographic
Primary Device ID06971355420819
NIH Device Record Key95d325c3-64b0-467c-a941-d8bc5f618d75
Commercial Distribution StatusIn Commercial Distribution
Brand NameECG module
Version Model NumberECG10
Company DUNS543063066
Company NameSHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971355420819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-04
Device Publish Date2022-01-27

Devices Manufactured by SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

06971355421267 - Diagnostic Ultrasound System2023-10-19
06971355421274 - Diagnostic Ultrasound System2023-10-19
06971355421281 - Diagnostic Ultrasound System2023-10-19
06971355421298 - Diagnostic Ultrasound System2023-10-19
06971355421304 - Diagnostic Ultrasound System2023-10-19
06971355421311 - Diagnostic Ultrasound System2023-10-19
06971355421328 - Diagnostic Ultrasound System2023-10-19
06971355421335 - Diagnostic Ultrasound System2023-10-19

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