Patient Monitoring Cable (SpO2 Extension Cable)— 510(k) K192404

Name: FDA 510(k) clearance K192404
Creator: U.S. Food and Drug Administration
Published: 2020-06-22

Substantially Equivalent

Shenzhen Coreray Technology, Ltd.

FDA 510(k) clearance K192404 for Patient Monitoring Cable (SpO2 Extension Cable), Substantially Equivalent on 2020-06-22. Applicant: Shenzhen Coreray Technology, Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Coreray Technology, Ltd.
Product code: Product code DSA
Device class: Class 2
Regulation: 21 CFR 870.2900
Advisory panel: Cardiovascular
Date received: 2019-09-03
Decision date: 2020-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DSA

product code DSA

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.