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510(k) Data Aggregation
K Number
K192404Device Name
Patient Monitoring Cable (SpO2 Extension Cable)
Manufacturer
Shenzhen Coreray Technology., Ltd
Date Cleared
2020-06-22
(293 days)
Product Code
DSA, DQA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Coreray Technology., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Patient Monitoring Cables are intended to be used to connect sensors, placed at appropriate sites on the patient to a monitoring device for general monitoring by health care professional.
Device Description
Patient Monitoring Cables (SpO2 Extension Cable, CR002-5301) is comprised of Plug, Cable/Leadwires and Connector. It's intended to plug into monitoring device and connect with SpO2 sensor, for transmitting signals which generated by SpO2 sensor to monitoring device.
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K Number
K172797Device Name
ECG Cable/Leadwires
Manufacturer
Shenzhen Coreray Technology., Ltd
Date Cleared
2018-02-28
(166 days)
Product Code
DSA
Regulation Number
870.2900Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Coreray Technology., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ECG Cable/Leadwires is intended to be used with ECG. The ECG Cable/Leadwires is used to connect electrodes placed at appropriate sites on the patient to ECG for general monitoring and/or diagnostic evaluation by health care professional.
Device Description
The ECG Cable/Leadwires is comprised of Plug, cable/leadwires and connector. The device is used to transmit ECG signals from electrodes which are affixed to the patient's body for both diagnostic and monitoring purposes. Each lead wire is attached to ECG patient electrodes. The leadwires connector plugs into one end of the external trunk cable which is plug into an ECG monitor.
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