FDA.reportPublic FDA data

510(k) K240646

Device
DreamClear
Applicant
Somnomed Technologies Inc., Doing Business AS Remware
510(k) number
K240646
Product code
GWL
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-04
Date received
2024-03-07
Regulation
882.1835
Classification name
Amplifier, Physiological Signal
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Arun Ramabadran
Address
601 S. Harbor Island Blvd. Suite 109 Tampa FL US 33602 33602

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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