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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 K010728
FOIA Releasable 510(k) K010728
Device Name HARMONE-SCHWARZER EEG SYSTEM
Applicant
STELLATE SYSTEMS
345 VICTORIA AVE., SUITE 300
WESTMOUNT, QUEBEC,  CA H3Z 2N2
Applicant Contact GEORGE PAPAGIANNIS
Correspondent
STELLATE SYSTEMS
345 VICTORIA AVE., SUITE 300
WESTMOUNT, QUEBEC,  CA H3Z 2N2
Correspondent Contact GEORGE PAPAGIANNIS
Regulation Number882.1400
Classification Product Code
OLV  
Subsequent Product Code
GWQ  
Date Received03/12/2001
Decision Date 05/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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