Class Class II
Vivo 45 LS (K233452)
Description
Vivo 45 LS by Breas Medical AB, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK233452
Clearance Date2025-01-13
Clearance TypeTraditional
Product CodeNOU
Regulation Number868.5895
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233452
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. Vivo 45 LS (K233452) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193586 | Vivo 45 LS | Breas Medical AB | 2021 |
| K131957 | MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIR... | Fisher & Paykel Healthcare, Ltd. | 2013 |
| K082724 | NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM | Newport Medical Instruments, Inc. | 2008 |
Trace the full predicate network for K233452
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.