QuantaFlo

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

SEMLER SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Semler Scientific, Inc. with the FDA for Quantaflo.

Pre-market Notification Details

Device IDK143094
510k NumberK143094
Device Name:QuantaFlo
ClassificationPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant SEMLER SCIENTIFIC, INC. 2330 NW EVERETT STREET Portland,  OR  97210
ContactBob Mcrae
CorrespondentBob Mcrae
SEMLER SCIENTIFIC, INC. 2330 NW EVERETT STREET Portland,  OR  97210
Product CodeJOM  
CFR Regulation Number870.2780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-28
Decision Date2015-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859433006123 K143094 000
00859433006079 K143094 000
00859433006062 K143094 000
00859433006048 K143094 000
00859433006024 K143094 000

Trademark Results [QuantaFlo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTAFLO
QUANTAFLO
88274741 5827470 Live/Registered
Semler Scientific, Inc.
2019-01-24

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