Class Class II
SV600, SV800 Ventilator (K243767)
Description
SV600, SV800 Ventilator by Shenzhen Mindray Bio-Medical Electronics Co., Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243767
Clearance Date2025-08-28
Clearance TypeTraditional
Product CodeCBK
Regulation Number868.5895
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243767
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. SV600, SV800 Ventilator (K243767) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electr... | 2023 |
| K213799 | N Series Patient Monitors | Shenzhen Mindray Bio-Medical Electr... | 2022 |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator S... | Maquet Critical Care AB | 2019 |
| K083050 | EVITE XL | Draeger Medical AG & Co. KG | 2008 |
Trace the full predicate network for K243767
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.