Vital Sign Monitoring Sensor (Model :XK300)— 510(k) K202464

Substantially Equivalent

Xandar Kardian, Inc.

FDA 510(k) clearance K202464 for Vital Sign Monitoring Sensor (Model :XK300), Substantially Equivalent on 2021-04-26. Applicant: Xandar Kardian, Inc..

Clearance details

Applicant: Xandar Kardian, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2020-08-27
Decision date: 2021-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.