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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 K133722
Device Name ASTHMA MONITOR AM3
Applicant
ERESEARCH TECHNOLOGY
1818 MARKET STREET, STE 1000
PHILADELPHIA,  PA  19103
Applicant Contact RICHARD A MILLER
Correspondent
ERESEARCH TECHNOLOGY
1818 MARKET STREET, STE 1000
PHILADELPHIA,  PA  19103
Correspondent Contact RICHARD A MILLER
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/05/2013
Decision Date 05/08/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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