FDA 510(k) Application Details - K190399

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K190399
Device Name	Oximeter
Applicant	Hancock Medical, Inc. 897 Independence Avenue, #3A Mountain View, CA 94043 US Other 510(k) Applications for this Company
Contact	Tom Goff 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	02/19/2019
Decision Date	08/05/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review