Cleared Traditional

K202464 - Vital Sign Monitoring Sensor (Model :XK300) (FDA 510(k) Clearance)

K202464 · Xandar Kardian, Inc. · Cardiovascular device

Apr 2021

Decision

242d

Days

Class 2

Risk

K202464 is an FDA 510(k) clearance for the Vital Sign Monitoring Sensor (Model :XK300). This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).

Submitted by Xandar Kardian, Inc. (Seoul, KR). The FDA issued a Cleared decision on April 26, 2021, 242 days after receiving the submission on August 27, 2020.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K202464 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 2020
Decision Date	April 26, 2021
Days to Decision	242 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF