Home / 510(k) Clearances / K143094

510(k) K143094

QuantaFlo by Semler Scientific, Inc. — Product Code JOM

K143094 is an FDA 510(k) premarket notification submitted by Semler Scientific, Inc. for the device "QuantaFlo". The FDA issued a decision of Substantially Equivalent on March 5, 2015. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780.

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

Other clearances for product code JOM

  • K220527 — PADnet Xpress (October 20, 2022)
  • K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (April 21, 2022)
  • K200567 — ASI Plethysmogrpah Analyzer (February 26, 2021)
  • K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system (December 11, 2020)
  • K191266 — VitalScan ANS (January 15, 2020)
  • K172655 — Automated ankle brachial pressure index measuring device (January 11, 2018)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K143152 — TM-ABI system (July 22, 2015)
  • K123921 — BODYTRONIC 200 (April 26, 2013)
  • K121108 — DOPPLEX ABILITY (January 3, 2013)

FDA data resources