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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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More FDA Info for this Product Code
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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