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FDA 510(k)

ULTRATHERM (908)

K-Number: K964083 · 1997-04-03

ApplicantSie-Med, Inc.
Decision Date1997-04-03
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRATHERM (908) is the device name listed in this FDA 510(k) record. The listed applicant is Sie-Med, Inc.. It received FDA 510(k) clearance on 1997-04-03 under 510(k) number K964083. 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 ULTRATHERM (908)?

ULTRATHERM (908) is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Sie-Med, Inc.. The 510(k) number is K964083.

When did ULTRATHERM (908) receive FDA 510(k) clearance?

ULTRATHERM (908) received FDA 510(k) clearance on 1997-04-03, under 510(k) number K964083.

Who is the listed applicant for ULTRATHERM (908)?

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

What is the FDA product code for ULTRATHERM (908)?

The FDA product code for ULTRATHERM (908) 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 Sie-Med, Inc. 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.

K003130REGUTHERM 952 THERMOGRAPHIC SYSTEM

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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