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FDA 510(k) Application Details - K040991
Device Classification Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
More FDA Info for this Device
510(K) Number
K040991
Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Applicant
AMBU, INC.
611 NORTH HAMMONDS FERRY ROAD
LINTHICUM, MD 21090-1356 US
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Contact
SANJAY PARIKH
Other 510(k) Applications for this Contact
Regulation Number
868.2600
More FDA Info for this Regulation Number
Classification Product Code
CAP
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More FDA Info for this Product Code
Date Received
04/16/2004
Decision Date
07/22/2004
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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