FDA 510(k) Application Details - K220351

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K220351
Device Name	Oximeter
Applicant	Chronisense Medical, Ltd. 2 Hacarmel St. P.O.B. 399 Yokneam Illit 2066724 IL Other 510(k) Applications for this Company
Contact	Bridget Ross 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	02/07/2022
Decision Date	11/18/2022
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