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FDA 510(k) Application Details - K161676
Device Classification Name
Spirometer, Diagnostic
More FDA Info for this Device
510(K) Number
K161676
Device Name
Spirometer, Diagnostic
Applicant
FIM MEDICAL
51 RUE PRIMAT CS 60194
Villeurbanne Cedex , Rhone 69625 FR
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Contact
LIZA PERRAT
Other 510(k) Applications for this Contact
Regulation Number
868.1840
More FDA Info for this Regulation Number
Classification Product Code
BZG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/17/2016
Decision Date
10/20/2016
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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