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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biofeedback
510(k) Number K981844
Device Name SLEEP MANAGEMENT SYSTEM
Applicant
Rmp, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Applicant Contact TERRY G MAHN
Correspondent
Rmp, Inc.
601 Thirteenth St. NW
Washington,  DC  20005
Correspondent Contact TERRY G MAHN
Regulation Number882.5050
Classification Product Code
HCC  
Date Received05/26/1998
Decision Date 08/07/1998
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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