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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 K010460
FOIA Releasable 510(k) K010460
Device Name LIFELINES TRACKIT
Applicant
Lifelines , Ltd.
P.O. Box 4341
Crofton,  MD  21114
Applicant Contact CRHISTINA SMITH
Correspondent
Lifelines , Ltd.
P.O. Box 4341
Crofton,  MD  21114
Correspondent Contact CRHISTINA SMITH
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received02/16/2001
Decision Date 05/14/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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