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 the device name listed in this FDA 510(k) record. The listed applicant is Viatherm Therapeutics, LLC. It received FDA 510(k) clearance on 2018-05-01 under 510(k) 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. The listed applicant is Viatherm Therapeutics, LLC. The 510(k) number is K173300.

When did ViaTherm BOOST receive FDA 510(k) clearance?

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

Who is the listed applicant for ViaTherm BOOST?

The FDA 510(k) record lists Viatherm Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViaTherm BOOST?

The FDA product code for ViaTherm BOOST is IMJ.

Other records listing Viatherm Therapeutics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250376ViVY

Related Devices (Code: IMJ)

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLC K243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K162240ProMedTek Model C1400 Shortwave Diathermy DevicePromedtek, Inc.

Official Source

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