The following data is part of a premarket notification filed by Shandong Corecare Technology Limited with the FDA for V-patch Cardiac Monitor.
| Device ID | K222842 |
| 510k Number | K222842 |
| Device Name: | V-Patch Cardiac Monitor |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | Shandong CoreCare Technology Limited Suite 801-2, Incubator Phase I, Innovation Valley, Jinan High-Tech Industrial Development Zone Jinan, CN |
| Contact | Cao Cheng |
| Correspondent | Prabhu Raghavan MDQR, LLC. 1790 Montemar Way San Jose, CA 95125 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-20 |
| Decision Date | 2022-10-20 |