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FDA 510(k)

Sonishield 100 Antimicrobial Ultrasound Gel

K-Number: K151070 · 2016-01-13

ApplicantQuotient Medical
Decision Date2016-01-13
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sonishield 100 Antimicrobial Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Quotient Medical. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K151070. 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 Sonishield 100 Antimicrobial Ultrasound Gel?

Sonishield 100 Antimicrobial Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Quotient Medical. The 510(k) number is K151070.

When did Sonishield 100 Antimicrobial Ultrasound Gel receive FDA 510(k) clearance?

Sonishield 100 Antimicrobial Ultrasound Gel received FDA 510(k) clearance on 2016-01-13, under 510(k) number K151070.

Who is the listed applicant for Sonishield 100 Antimicrobial Ultrasound Gel?

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

What is the FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel?

The FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel is MUI.

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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