Class Class II
Handheld Pulse Oximeter (K213431)
Description
Handheld Pulse Oximeter by Shenzhen Witleaf Medical Electronics Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK213431
Clearance Date2023-02-26
Clearance TypeTraditional
Product CodeDQA
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213431
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. Handheld Pulse Oximeter (K213431) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201468 | Pulse Oximeter | Shenzhen Creative Industry Co., Ltd. | 2021 |
Trace the full predicate network for K213431
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.