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FDA 510(k)

ProMedTek Model C1400 Shortwave Diathermy Device

K-Number: K162240 · 2016-11-17

ApplicantPromedtek, Inc.
Decision Date2016-11-17
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ProMedTek Model C1400 Shortwave Diathermy Device is the device name listed in this FDA 510(k) record. The listed applicant is Promedtek, Inc.. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162240. 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 ProMedTek Model C1400 Shortwave Diathermy Device?

ProMedTek Model C1400 Shortwave Diathermy Device is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Promedtek, Inc.. The 510(k) number is K162240.

When did ProMedTek Model C1400 Shortwave Diathermy Device receive FDA 510(k) clearance?

ProMedTek Model C1400 Shortwave Diathermy Device received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162240.

Who is the listed applicant for ProMedTek Model C1400 Shortwave Diathermy Device?

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

What is the FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device?

The FDA product code for ProMedTek Model C1400 Shortwave Diathermy Device is IMJ.

Related Devices (Code: IMJ)

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.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC

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.

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