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FDA 510(k)

THEE THERMASTIM

K-Number: K962703 · 1997-02-21

ApplicantEhti Medical Corp.
Decision Date1997-02-21
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THEE THERMASTIM is the device name listed in this FDA 510(k) record. The listed applicant is Ehti Medical Corp.. It received FDA 510(k) clearance on 1997-02-21 under 510(k) number K962703. 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 THEE THERMASTIM?

THEE THERMASTIM is a medical device that received FDA 510(k) clearance on 1997-02-21. The listed applicant is Ehti Medical Corp.. The 510(k) number is K962703.

When did THEE THERMASTIM receive FDA 510(k) clearance?

THEE THERMASTIM received FDA 510(k) clearance on 1997-02-21, under 510(k) number K962703.

Who is the listed applicant for THEE THERMASTIM?

The FDA 510(k) record lists Ehti Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THEE THERMASTIM?

The FDA product code for THEE THERMASTIM is IMJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ehti Medical Corp. 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.

K962243VASOTHERM

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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