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FDA 510(k) Application Details - K051779
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K051779
Device Name
Monitor, Breathing Frequency
Applicant
ANDROMED, INC.
4610 CHEMIN DU BOIS-FRANC
SAINT LAURENT, QUEBEC H4S 1A7 CA
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Contact
GEORGE PAPAGIANNIS
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Regulation Number
868.2375
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Classification Product Code
BZQ
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More FDA Info for this Product Code
Date Received
07/01/2005
Decision Date
09/30/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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