Class Class II
Mecun SpO2 sensor (K231979)
Description
Mecun SpO2 sensor by Shenzhen Mecun Medical Supply Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK231979
Clearance Date2024-08-16
Clearance TypeTraditional
Product CodeDQA
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K231979
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. Mecun SpO2 sensor (K231979) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201360 | Reusable and Disposable SpO2 Sensors | Xinkang Medical Instrument Co. , Ltd. | 2020 |
Trace the full predicate network for K231979
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.