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FDA 510(k) Application Details - K081037
Device Classification Name
Ventilatory Effort Recorder
More FDA Info for this Device
510(K) Number
K081037
Device Name
Ventilatory Effort Recorder
Applicant
ITAMAR MEDICAL
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
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Contact
JOHATHAN S KAHAN
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
04/11/2008
Decision Date
06/09/2008
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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