Class Class II
Finger Pulse Oximeter, Model: X1906P (K221798)
Description
Finger Pulse Oximeter, Model: X1906P by Shenzhen Changkun Technology Co., Ltd., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221798
Clearance Date2023-05-04
Clearance TypeTraditional
Product CodeDQA
Regulation Number870.2700
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221798
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. Finger Pulse Oximeter, Model: X1906P (K221798) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160268 | Fingertip Pulse Oximeter MD300CG11/MD300CG51 | Beijing Choice Electronic Technolog... | 2016 |
Trace the full predicate network for K221798
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.