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FDA 510(k) Application Details - K003704
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K003704
Device Name
Monitor, Breathing Frequency
Applicant
OPTOVENT AB
1350 15TH STREET, SUITE 4H
FORT LEE, NJ 07024 US
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Contact
CLAES RYMOND
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
12/01/2000
Decision Date
02/05/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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