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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, predicted values, pulmonary function
510(k) Number K173937
Device Name SpiroSphere
Applicant
eResearchTechnology GmbH
Sieboldstrasse 3
Estenfeld,  DE 97230
Applicant Contact Johannes Thalhammer
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact DAWN M TIBODEAU
Regulation Number868.1890
Classification Product Code
BTY  
Date Received12/26/2017
Decision Date 02/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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