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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 K111055
Device Name GALAXY SYSTEM; JUPITER
Applicant
PERSONAL HEALTH INSTITUTE INTERNATIONAL
263 CEDAR CREEK DRIVE
BATTLE CREEK,  MI  49015
Applicant Contact KUMAR KULKARNI
Correspondent
PERSONAL HEALTH INSTITUTE INTERNATIONAL
263 CEDAR CREEK DRIVE
BATTLE CREEK,  MI  49015
Correspondent Contact KUMAR KULKARNI
Regulation Number882.1400
Classification Product Code
OLV  
Date Received04/15/2011
Decision Date 12/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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