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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amplifier, Physiological Signal
510(k) Number K240646
Device Name DreamClear
Applicant
Somnomed Technologies Inc., Doing Business AS Remware
601 S. Harbor Island Blvd.
Suite 109
Tampa,  FL  33602
Applicant Contact Arun Ramabadran
Correspondent
Husch Blackwell Llp
1801 Pennyslvania Ave., NW, Suite 1000
Washington,  DC  20006
Correspondent Contact Seth Mailhot
Regulation Number882.1835
Classification Product Code
GWL  
Subsequent Product Codes
DQA   MNR  
Date Received03/07/2024
Decision Date 09/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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