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FDA 510(k)

ULTRAEKOGEL MODELS EK 2000 & EK 2001

K-Number: K030889 · 2003-05-23

ApplicantInmed Ltda.
Decision Date2003-05-23
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAEKOGEL MODELS EK 2000 & EK 2001 is the device name listed in this FDA 510(k) record. The listed applicant is Inmed Ltda.. It received FDA 510(k) clearance on 2003-05-23 under 510(k) number K030889. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAEKOGEL MODELS EK 2000 & EK 2001?

ULTRAEKOGEL MODELS EK 2000 & EK 2001 is a medical device that received FDA 510(k) clearance on 2003-05-23. The listed applicant is Inmed Ltda.. The 510(k) number is K030889.

When did ULTRAEKOGEL MODELS EK 2000 & EK 2001 receive FDA 510(k) clearance?

ULTRAEKOGEL MODELS EK 2000 & EK 2001 received FDA 510(k) clearance on 2003-05-23, under 510(k) number K030889.

Who is the listed applicant for ULTRAEKOGEL MODELS EK 2000 & EK 2001?

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

What is the FDA product code for ULTRAEKOGEL MODELS EK 2000 & EK 2001?

The FDA product code for ULTRAEKOGEL MODELS EK 2000 & EK 2001 is MUI.

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.

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Other records listing Inmed Ltda. 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.

K030081CSF400 AND CSF600K030887LEKTROGEL, MODEL LK3001

Related Devices (Code: MUI)

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.

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

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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