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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
Eresearch Technology
Sieboldstrasse 3
Estenfeld,  DE 97230
Applicant Contact Kristin Feld
Correspondent
Eresearch Technology
500 Rutherford Ave.
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
Predetermined Change
Control Plan Authorized		 No
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