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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automatic event detection software for polysomnograph with electroencephalograph
510(k) Number K040595
Device Name ALICE 5
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE,  PA  15668 -8550
Applicant Contact ZITA A YURKO
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number882.1400
Classification Product Code
OLZ  
Subsequent Product Code
OLV  
Date Received03/08/2004
Decision Date 03/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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