FDA 510(k) Application Details - K220899

Device Classification Name

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510(K) Number K220899
Device Name Oxehealth Vital Signs
Applicant Oxehealth Limited
Magdalen Centre North, The Oxford Science Park
Oxford OX4 4GA GB
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Contact Iain Charlton
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Regulation Number

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Classification Product Code QME
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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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