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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 a medical device manufactured by Somnomed Technologies Inc., Doing Business AS Remware. It received FDA 510(k) clearance on 2024-09-04 under approval 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. It is manufactured by Somnomed Technologies Inc., Doing Business AS Remware. The 510(k) number is K240646.

When was DreamClear approved by the FDA?

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

What company makes DreamClear?

DreamClear is manufactured by Somnomed Technologies Inc., Doing Business AS Remware.

What is the FDA product code for DreamClear?

The FDA product code for DreamClear is GWL.

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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.

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