QuantaFlo— 510(k) K143094

Substantially Equivalent

Semler Scientific, Inc.

FDA 510(k) clearance K143094 for QuantaFlo, Substantially Equivalent on 2015-03-05. Applicant: Semler Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Semler Scientific, Inc.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2014-10-28
Decision date: 2015-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOM

K220527 — PADnet Xpress2022-10-20
K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI2022-04-21
K200567 — ASI Plethysmogrpah Analyzer2021-02-26
K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system2020-12-11
K191266 — VitalScan ANS2020-01-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.