FDA 510(k) Application Details - K143094

Device Classification Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic   More FDA Info for this Device
510(K) Number	K143094
Device Name	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant	SEMLER SCIENTIFIC, INC. 2330 NW EVERETT STREET PORTLAND, OR 97210 US Other 510(k) Applications for this Company
Contact	BOB MCRAE 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	10/28/2014
Decision Date	03/05/2015
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