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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Standard Polysomnograph With Electroencephalograph
510(k) Number K240700
Device Name HomeSleepTest (HST, HST REM+)
Applicant
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE 97236
Applicant Contact Cherita James
Correspondent
Propharma Group
1129 20th St. NW Suite 600
Washington,  DC  20036
Correspondent Contact Cherita James
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
MNR  
Date Received03/14/2024
Decision Date 12/08/2024
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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