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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 K971867
Device Name ALICE 4R SYSTEM
Applicant
Healthdyne Technologies, Inc.
1850 Pkwy. Pl.
Marietta,  GA  30067
Applicant Contact TIMOTHY Y COWART
Correspondent
Healthdyne Technologies, Inc.
1850 Pkwy. Pl.
Marietta,  GA  30067
Correspondent Contact TIMOTHY Y COWART
Regulation Number882.1400
Classification Product Code
OLV  
Date Received05/20/1997
Decision Date 08/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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