Class Class II
Model 9160 VitaloQUB (K223818)
Description
Model 9160 VitaloQUB by Vitalograph Ireland, Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223818
Clearance Date2023-05-25
Clearance TypeTraditional
Product CodeJEH
Regulation Number868.1760
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223818
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. Model 9160 VitaloQUB (K223818) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213872 | ComPAS2 | Morgan Scientific, Inc. | 2022 |
| K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022 |
| K022636 | BODY BOX 5500 | Morgan Scientific, Inc. | 2003 |
Trace the full predicate network for K223818
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.