FDA 510(k) Application Details - K213515

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K213515
Device Name	Oximeter
Applicant	Wesper Inc. 234 5th Ave New York, NY 10001 US Other 510(k) Applications for this Company
Contact	Amir Reuveny 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	11/02/2021
Decision Date	06/10/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review