Class Class II
WatchPAT ONE (WP1) (K223675)
Description
WatchPAT ONE (WP1) by Itamar Medical , Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223675
Clearance Date2023-01-06
Clearance TypeSpecial
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223675
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. WatchPAT ONE (WP1) (K223675) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222331 | WatchPAT300 (WP300) | Itamar Medical , Ltd. | 2022 |
| K183559 | WatchPAT ONE | Itamar Medical , Ltd. | 2019 |
Trace the full predicate network for K223675
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.