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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 Hwy. 8 NW
New Brighton,  MN  55112
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
Predetermined Change
Control Plan Authorized		 No
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