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FDA 510(k) Application Details - K080922
Device Classification Name
Monitor, Breathing Frequency
More FDA Info for this Device
510(K) Number
K080922
Device Name
Monitor, Breathing Frequency
Applicant
SALTER LABS, DIVISION OF REGULATORY AFFAIRS
100 WEST SYCAMORE RD.
ARVIN, CA 93203 US
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Contact
DUANE KAZAL
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
04/01/2008
Decision Date
07/25/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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