FDA 510(k) Application Details - K211906

Device Classification Name	More FDA Info for this Device
510(K) Number	K211906
Device Name	Vital Signs
Applicant	Oxehealth Limited Magdalen Centre 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	06/21/2021
Decision Date	07/20/2021
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