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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Spirometer, Diagnostic
510(k) Number K183479
Device Name Asthma Monitor AM3
Applicant
eResearchTechnology
Sieboldstrasse 3
Estenfeld,  DE 97230
Applicant Contact Kristin Feld
Correspondent
eResearchTechnology
500 Rutherford Avenue
Boston,  MA  02129
Correspondent Contact Mingzi Deng
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/17/2018
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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