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FDA 510(k) Application Details - K220899
Device Classification Name
More FDA Info for this Device
510(K) Number
K220899
Device Name
Oxehealth Vital Signs
Applicant
Oxehealth Limited
Magdalen Centre North, The Oxford Science Park
Oxford OX4 4GA GB
Other 510(k) Applications for this Company
Contact
Iain Charlton
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Regulation Number
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Classification Product Code
QME
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/28/2022
Decision Date
04/29/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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