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FDA 510(k) Application Details - K103316
Device Classification Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
More FDA Info for this Device
510(K) Number
K103316
Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Applicant
VAPOTHERM, INC.
198 Log Canoe Circle
Stevensville, MD 21666 US
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Contact
GREGORY A WHITNEY
Other 510(k) Applications for this Contact
Regulation Number
868.5450
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Classification Product Code
BTT
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More FDA Info for this Product Code
Date Received
11/10/2010
Decision Date
02/08/2011
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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