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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 K143272
Device Name ApneaLink Air
Applicant
RESMED GERMANY INC.
FRAUNHOFERSTR. 16
MARTINSRIED,  DE 82152
Applicant Contact Sandra Grunwald
Correspondent
RESMED GERMANY INC.
FRAUNHOFERSTR. 16
MARTINSRIED,  DE 82152
Correspondent Contact Sandra Grunwald
Regulation Number868.2375
Classification Product Code
MNR  
Date Received11/14/2014
Decision Date 04/30/2015
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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