Class Class II
Family of DIMAR DMAX NIV masks (K232836)
Description
Family of DIMAR DMAX NIV masks by Dimar S.P.A., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK232836
Clearance Date2024-08-14
Clearance TypeTraditional
Product CodeCBK
Regulation Number868.5895
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K232836
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. Family of DIMAR DMAX NIV masks (K232836) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K072588 | PERFORMAX SE TOTAL FACE MASK | Respironics Inc., Sleep & Home Resp... | 2007 |
Trace the full predicate network for K232836
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.