FDA 510(k) Application Details - K010761

Device Classification Name Spirometer, Diagnostic

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510(K) Number K010761
Device Name Spirometer, Diagnostic
Applicant FIM MEDICAL
30 RUE CAMILLE
LYON 69003 FR
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Contact ERIC DEREI
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 03/13/2001
Decision Date 03/05/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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