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FDA 510(k) Application Details - K110486
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K110486
Device Name
Ventilatory Effort Recorder
Applicant
NOVASOM, INC.
801 CROMWELL PARK DRIVE
GLEN BURNIE, MD 21061 US
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Contact
ROGER K RICHARDSON
Other 510(k) Applications for this Contact
Regulation Number
868.2375
More FDA Info for this Regulation Number
Classification Product Code
MNR
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More FDA Info for this Product Code
Date Received
02/22/2011
Decision Date
08/12/2011
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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