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FDA 510(k) Application Details - DEN200019
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN200019
Device Name
Oxehealth Vital Signs
Applicant
Oxehealth Limited
Magdalen Center North, the Oxford Science Park
Oxford OX4 4GA GB
Other 510(k) Applications for this Company
Contact
Hugh Lloyd-Jukes
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QME
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/27/2020
Decision Date
03/26/2021
Decision
DENG -
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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