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FDA 510(k) Application Details - K001743
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
RICHARD A BONATO
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
BZQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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