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FDA 510(k)

ULTRATHERM 808 I

K-Number: K862589 · 1986-08-01

ApplicantElmed, Inc.
Decision Date1986-08-01
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRATHERM 808 I is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1986-08-01 under 510(k) number K862589. 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 808 I?

ULTRATHERM 808 I is a medical device that received FDA 510(k) clearance on 1986-08-01. The listed applicant is Elmed, Inc.. The 510(k) number is K862589.

When did ULTRATHERM 808 I receive FDA 510(k) clearance?

ULTRATHERM 808 I received FDA 510(k) clearance on 1986-08-01, under 510(k) number K862589.

Who is the listed applicant for ULTRATHERM 808 I?

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

What is the FDA product code for ULTRATHERM 808 I?

The FDA product code for ULTRATHERM 808 I is IMJ.

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Other records listing Elmed, 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

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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

View on FDA Database →

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

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