510(k) K143094

QuantaFlo by Semler Scientific, Inc. — Product Code JOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2015
Date Received
October 28, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device Class
Class II
Regulation Number
870.2780
Review Panel
CV
Submission Type