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FDA 510(k)

Patient Monitoring Cable (SpO2 Extension Cable)

K-Number: K192404 · 2020-06-22

ApplicantShenzhen Coreray Technology, Ltd.
Decision Date2020-06-22
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitoring Cable (SpO2 Extension Cable) is a medical device manufactured by Shenzhen Coreray Technology, Ltd.. It received FDA 510(k) clearance on 2020-06-22 under approval number K192404. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Monitoring Cable (SpO2 Extension Cable)?

Patient Monitoring Cable (SpO2 Extension Cable) is a medical device that received FDA 510(k) clearance on 2020-06-22. It is manufactured by Shenzhen Coreray Technology, Ltd.. The 510(k) number is K192404.

When was Patient Monitoring Cable (SpO2 Extension Cable) approved by the FDA?

Patient Monitoring Cable (SpO2 Extension Cable) received FDA 510(k) clearance on 2020-06-22, under approval number K192404.

What company makes Patient Monitoring Cable (SpO2 Extension Cable)?

Patient Monitoring Cable (SpO2 Extension Cable) is manufactured by Shenzhen Coreray Technology, Ltd..

What is the FDA product code for Patient Monitoring Cable (SpO2 Extension Cable)?

The FDA product code for Patient Monitoring Cable (SpO2 Extension Cable) is DSA.

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Related PubMed Literature

PMID: 41694722 Lessons from global materiovigilance systems: What India can learn? Perspectives in clinical research (2026) PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025)

Other Devices by Shenzhen Coreray Technology, Ltd.

K173368Reusable & Disposable SpO2 Sensors K172797ECG Cable/Leadwires

Related Devices (Code: DSA)

K153188Caremed patient cable and leadwiresShenzhen Caremed Medical Technology Co., Ltd. K152947Disposable Temporary Pacing CableTiger Medical Products K172591Fixed Patient Leads ECG Cable (Model 3153)Boston Scientific Corporation K162768ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cablesIntegral Process Sas K163316Multi-Link X2 ECG Adapter and Direct Connect Lead Wire SystemCarefusion 303, Inc. K170536ECG Disposable Lead WireAPK Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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