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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
Applicant Contact DAVID D'CRUZ
Correspondent
Resmed Germany, Inc.
14040 Danielson St.
Poway,  CA  92064
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
Predetermined Change
Control Plan Authorized		 No
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