Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ViaTherm BOOST

K-Number: K173300 · 2018-05-01

Decision Date2018-05-01
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ViaTherm BOOST is a medical device manufactured by Viatherm Therapeutics, LLC. It received FDA 510(k) clearance on 2018-05-01 under approval number K173300. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViaTherm BOOST?

ViaTherm BOOST is a medical device that received FDA 510(k) clearance on 2018-05-01. It is manufactured by Viatherm Therapeutics, LLC. The 510(k) number is K173300.

When was ViaTherm BOOST approved by the FDA?

ViaTherm BOOST received FDA 510(k) clearance on 2018-05-01, under approval number K173300.

What company makes ViaTherm BOOST?

ViaTherm BOOST is manufactured by Viatherm Therapeutics, LLC.

What is the FDA product code for ViaTherm BOOST?

The FDA product code for ViaTherm BOOST is IMJ.

Other Devices by Viatherm Therapeutics, LLC

Related Devices (Code: IMJ)

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.