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FDA 510(k) Application Details - K072845
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K072845
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
VAPOTHERM, INC.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 21666 US
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Contact
JONATHAN S KAHN
Other 510(k) Applications for this Contact
Regulation Number
868.5450
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Classification Product Code
BTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/04/2007
Decision Date
07/17/2008
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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