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FDA 510(k) Application Details - K221318
Device Classification Name
More FDA Info for this Device
510(K) Number
K221318
Device Name
HVT 2.0
Applicant
Vapotherm Inc.
100 Domain Drive
Exeter, NH 03833 US
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Contact
Michael J. Webb
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Regulation Number
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Classification Product Code
QAV
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Date Received
05/06/2022
Decision Date
12/13/2022
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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