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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 K140861
Device Name SOMNOTOUCH RESP
Applicant
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE D-97236
Applicant Contact MATTHIAS BROENNER
Correspondent
Somnomedics GmbH
Am Sonnenstuhl 63
Randersacker,  DE D-97236
Correspondent Contact MATTHIAS BROENNER
Regulation Number868.2375
Classification Product Code
MNR  
Date Received04/03/2014
Decision Date 01/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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