FDA 510(k) Application Details - K001743

Device Classification Name Monitor, Breathing Frequency

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510(K) Number K001743
Device Name Monitor, Breathing Frequency
Applicant BRAEBON MEDICAL CORP.
120 WALGREEN DR (RR#3)
SUITE #1
CARP, ONTARIO K0A 1L0 CA
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Contact RICHARD A BONATO
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Regulation Number 868.2375

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Classification Product Code BZQ
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Date Received 06/08/2000
Decision Date 08/25/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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