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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, sleep assessment
510(k) Number K965079
Device Name SOMNITOR 32K SLEEP ACTIVITY MONITOR
Applicant
NEURIM PHARMACEUTICALS, LTD.
12300 TWINBROOK PARKWAY, SUIT5
ROCKVILLE,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
NEURIM PHARMACEUTICALS, LTD.
12300 TWINBROOK PARKWAY, SUIT5
ROCKVILLE,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number882.5050
Classification Product Code
LEL  
Date Received12/19/1996
Decision Date 07/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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