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FDA 510(k)

Ultra/Phonic Free Conductivity Gel

K-Number: K163027 · 2018-01-09

ApplicantPharmaceutical Innovations, Inc.
Decision Date2018-01-09
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultra/Phonic Free Conductivity Gel is the device name listed in this FDA 510(k) record. The listed applicant is Pharmaceutical Innovations, Inc.. It received FDA 510(k) clearance on 2018-01-09 under 510(k) number K163027. 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 Ultra/Phonic Free Conductivity Gel?

Ultra/Phonic Free Conductivity Gel is a medical device that received FDA 510(k) clearance on 2018-01-09. The listed applicant is Pharmaceutical Innovations, Inc.. The 510(k) number is K163027.

When did Ultra/Phonic Free Conductivity Gel receive FDA 510(k) clearance?

Ultra/Phonic Free Conductivity Gel received FDA 510(k) clearance on 2018-01-09, under 510(k) number K163027.

Who is the listed applicant for Ultra/Phonic Free Conductivity Gel?

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

What is the FDA product code for Ultra/Phonic Free Conductivity Gel?

The FDA product code for Ultra/Phonic Free Conductivity Gel is MUI.

Other records listing Pharmaceutical Innovations, 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.

K163026Ultra/Phonic Scanning GelK163024Ultra/Phonic Conductivity GelK163023Other-Sonic Transmission Gel

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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