FDA 510(k) Application Details - K191266

Device Classification Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic   More FDA Info for this Device
510(K) Number	K191266
Device Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant	Medeia, Inc. 7 W Figueroa Street, Suites 300 Santa Barbara, CA 93101 US Other 510(k) Applications for this Company
Contact	Slav Danev Other 510(k) Applications for this Contact
Regulation Number	870.2780   More FDA Info for this Regulation Number
Classification Product Code	JOM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2019
Decision Date	01/15/2020
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