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FDA 510(k)

FluidSmart

K-Number: K172048 · 2017-09-05

ApplicantThermedx, LLC
Decision Date2017-09-05
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FluidSmart is a medical device manufactured by Thermedx, LLC. It received FDA 510(k) clearance on 2017-09-05 under approval number K172048. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FluidSmart?

FluidSmart is a medical device that received FDA 510(k) clearance on 2017-09-05. It is manufactured by Thermedx, LLC. The 510(k) number is K172048.

When was FluidSmart approved by the FDA?

FluidSmart received FDA 510(k) clearance on 2017-09-05, under approval number K172048.

What company makes FluidSmart?

FluidSmart is manufactured by Thermedx, LLC.

What is the FDA product code for FluidSmart?

The FDA product code for FluidSmart is HIG.

Other Devices by Thermedx, LLC

K210628X-FLO Fluid Management System

Related Devices (Code: HIG)

K180735Endomat SelectKarl Storz SE & CO. KG K180825Fluent Fluid Management SystemHologic, Inc. K173489GYN-Pump PH304W.O.M. World of Medicine GmbH K172040Aquilex Fluid Control System AQL-100SW.O.M. World of Medicine GmbH K201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG K210628X-FLO Fluid Management SystemThermedx, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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