Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (K213825)
Description
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K213825
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. Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (K213825) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K061261 | L4 OXYGEN CONCENTRATOR | Respironics, Inc. | 2006 |
Trace the full predicate network for K213825
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.