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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K083620
Device Name SOMNOLYZER 24X7
Applicant
THE SIESTA GROUP NORTH AMERICA
990 WASHINGTON STREET
SUITE 204
DEDHAM,  MA  02026
Applicant Contact ZVI LADIN
Correspondent
THE SIESTA GROUP NORTH AMERICA
990 WASHINGTON STREET
SUITE 204
DEDHAM,  MA  02026
Correspondent Contact ZVI LADIN
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/08/2008
Decision Date 03/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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