Class Class II
DormoTech NLab (K242290)
Description
DormoTech NLab by Dormotech Medical, Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242290
Clearance Date2025-01-08
Clearance TypeTraditional
Product CodeMNR
Regulation Number868.2375
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242290
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. DormoTech NLab (K242290) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230148 | Vlab | Dormotech Medical, Ltd. | 2023 |
| K082113 | NOX T3, NOXTURNAL (PC APPLICATION) | Nox Medical | 2008 |
| K040380 | DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR,... | Dolphin Medical, Inc. | 2004 |
| K021089 | OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR | Nellcor Puritan Bennett, Inc. | 2002 |
Trace the full predicate network for K242290
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.