Cleared Traditional

K222842 - V-Patch Cardiac Monitor
(FDA 510(k) Clearance)

K222842 · Shandong Corecare Technology Limited · Cardiovascular

Oct 2022

Decision

30d

Days

Class 2

Risk

K222842 is an FDA 510(k) clearance for the V-Patch Cardiac Monitor. This device is classified as a Transmitters And Receivers, Electrocardiograph, Telephone (Class II — Special Controls, product code DXH).

Submitted by Shandong Corecare Technology Limited (Jinan, CN). The FDA issued a Cleared decision on October 20, 2022, 30 days after receiving the submission on September 20, 2022.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2920.

Submission Details

510(k) Number	K222842 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2022
Decision Date	October 20, 2022
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF