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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
510(k) Number K143094
Device Name QuantaFlo
Applicant
Semler Scientific, Inc.
2330 NW Everett St.
Portland,  OR  97210
Applicant Contact BOB MCRAE
Correspondent
Semler Scientific, Inc.
2330 NW Everett St.
Portland,  OR  97210
Correspondent Contact BOB MCRAE
Regulation Number870.2780
Classification Product Code
JOM  
Date Received10/28/2014
Decision Date 03/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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