FDA 510(k) Application Details - K133722

Device Classification Name Spirometer, Diagnostic

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510(K) Number K133722
Device Name Spirometer, Diagnostic
Applicant ERESEARCH TECHNOLOGY
1818 MARKET STREET, STE 1000
PHILADELPHIA, PA 19103 US
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Contact RICHARD A MILLER
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 12/05/2013
Decision Date 05/08/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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