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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.
PO BOX 4341
CROFTON,  MD  21114
Applicant Contact CRHISTINA SMITH
Correspondent
LIFELINES LTD.
PO 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
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