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FDA 510(k) Application Details - K171899
Device Classification Name
Chamber, Hyperbaric
More FDA Info for this Device
510(K) Number
K171899
Device Name
Chamber, Hyperbaric
Applicant
Oxavita S.R.L.
Tamborini 5813
Buenos Aires AR
Other 510(k) Applications for this Company
Contact
Eduardo Northing
Other 510(k) Applications for this Contact
Regulation Number
868.5470
More FDA Info for this Regulation Number
Classification Product Code
CBF
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More FDA Info for this Product Code
Date Received
06/26/2017
Decision Date
11/22/2019
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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