ECG module

GUDID 06971355420819

AHA

SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.

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• Primary Device ID: 06971355420819
• NIH Device Record Key: 95d325c3-64b0-467c-a941-d8bc5f618d75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECG module
• Version Model Number: ECG10
• Company DUNS: 543063066
• Company Name: SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971355420819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210154

FDA Product Code

• IYN: System, Imaging, Pulsed Doppler, Ultrasonic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-04
• Device Publish Date: 2022-01-27

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

• 06971355421267 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421274 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421281 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421298 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421304 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421311 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421328 - Diagnostic Ultrasound System: 2023-10-19
• 06971355421335 - Diagnostic Ultrasound System: 2023-10-19