FDA 510(k) Application Details - K201887

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K201887
Device Name	Oximeter
Applicant	SurePulse Medical Limited Medicity, D6 Thane Road Nottingham NG90 gbh GB Other 510(k) Applications for this Company
Contact	James Carpenter Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/08/2020
Decision Date	07/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review