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FDA 510(k) Application Details - K090958
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K090958
Device Name
Ventilatory Effort Recorder
Applicant
INO THERAPEUTICS LLC
2902 DAIRY DR.
MADISON, WI 53718 US
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DAVID TRUEBLOOD
Other 510(k) Applications for this Contact
Regulation Number
868.2375
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Classification Product Code
MNR
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More FDA Info for this Product Code
Date Received
04/06/2009
Decision Date
06/18/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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