Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568)
Description
Wrist Blood Pressure Monitor (OHMS11, OHMS12) by Shenzhen Zhongkemingwang Telecommunications Software Corp., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242568
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Wrist Blood Pressure Monitor (OHMS11, OHMS12) (K242568) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | Microlife Intellectual Property GmbH | 2021 |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Omron Healthcare, Inc. | 2018 |
Trace the full predicate network for K242568
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.