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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact