FDA 510(k) Application Details - K072722

Device Classification Name Spirometer, Diagnostic

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510(K) Number K072722
Device Name Spirometer, Diagnostic
Applicant MEDDORNA LLC
11874 SOUTH EVELYN CIRCLE
HOUSTON, TX 77071 US
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Contact J. HARVEY KNAUSS
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 09/26/2007
Decision Date 04/24/2008
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 Y
Expedited Review



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