Home / 510(k) Clearances / K222842

510(k) K222842

V-Patch Cardiac Monitor by Shandong Corecare Technology Limited — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2022
Date Received
September 20, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
Review Panel
CV
Submission Type

Other clearances for product code DXH

  • K250233 — PreemptiveAI Clinical SDK (February 13, 2026)
  • K250258 — HeartBeam AIMIGo with 12-L ECG Synthesis Software System (December 8, 2025)
  • K243438 — MEMO Patch M (MPT-E08R-UNC01) (December 5, 2025)
  • K243981 — Hexoskin Medical System (7100-00016) (November 18, 2025)
  • K243003 — VitalSigns 1-Lead Holter (VSH101) (June 17, 2025)
  • K233521 — QT ECG (QTERD100) (December 6, 2023)
  • K220795 — QT ECG (September 26, 2022)
  • K213357 — Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Puls (July 19, 2022)
  • K220350 — KardiaMobile 6L (May 25, 2022)
  • K211668 — KardiaMobile Card (November 30, 2021)