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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 K083575
Device Name APNEALINK PLUS, MODEL: 22328
Applicant
RESMED GERMANY INC.
14040 DANIELSON ST.
POWAY,  CA  92064 -6857
Applicant Contact DAVID D'CRUZ
Correspondent
RESMED GERMANY INC.
14040 DANIELSON ST.
POWAY,  CA  92064 -6857
Correspondent Contact DAVID D'CRUZ
Regulation Number868.2375
Classification Product Code
MNR  
Date Received12/03/2008
Decision Date 03/19/2009
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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