Class Class II
DreamClear (K240646)
Description
DreamClear by Somnomed Technologies Inc., Doing Business AS Remware, an FDA 510(k) cleared neurology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240646
Clearance Date2024-09-04
Clearance TypeTraditional
Product CodeGWL
Regulation Number882.1835
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240646
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. DreamClear (K240646) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K092699 | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 | Neurotronics, Inc. | 2010 |
| K090484 | ALICE PDX | Respironics Inc., Sleep & Home Resp... | 2009 |
Trace the full predicate network for K240646
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.