FDA 510(k) Application Details - K051779

Device Classification Name Monitor, Breathing Frequency

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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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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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