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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 K131932
Device Name APNEALINK PRO
Applicant
Resmed Germany, Inc.
Fraunhoferstrasse 16
Martinsried,  DE D-82152
Applicant Contact SANDRA GRUNWALD
Correspondent
Resmed Germany, Inc.
Fraunhoferstrasse 16
Martinsried,  DE D-82152
Correspondent Contact SANDRA GRUNWALD
Regulation Number868.2375
Classification Product Code
MNR  
Date Received06/27/2013
Decision Date 11/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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