FDA 510(k)

DreamClear

K-Number: K240646 · 2024-09-04

ApplicantSomnomed Technologies Inc., Doing Business AS Remware

Decision Date2024-09-04

Product CodeGWL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

DreamClear is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed Technologies Inc., Doing Business AS Remware. It received FDA 510(k) clearance on 2024-09-04 under 510(k) number K240646. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DreamClear?

DreamClear is a medical device that received FDA 510(k) clearance on 2024-09-04. The listed applicant is Somnomed Technologies Inc., Doing Business AS Remware. The 510(k) number is K240646.

When did DreamClear receive FDA 510(k) clearance?

DreamClear received FDA 510(k) clearance on 2024-09-04, under 510(k) number K240646.

Who is the listed applicant for DreamClear?

The FDA 510(k) record lists Somnomed Technologies Inc., Doing Business AS Remware as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DreamClear?

The FDA product code for DreamClear is GWL.

Related Devices (Code: GWL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243746Delphi AmplifierQuantalx Neroscience K242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K232210X-trodes System MX-Trodes K230148VlabDormotech Medical, Ltd.K223676SomniCheckBrainmatterz, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.