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 a medical device manufactured by Quotient Medical. It received FDA 510(k) clearance on 2016-01-13 under approval 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. It is manufactured by Quotient Medical. The 510(k) number is K151070.
When was Sonishield 100 Antimicrobial Ultrasound Gel approved by the FDA?
Sonishield 100 Antimicrobial Ultrasound Gel received FDA 510(k) clearance on 2016-01-13, under approval number K151070.
What company makes Sonishield 100 Antimicrobial Ultrasound Gel?
Sonishield 100 Antimicrobial Ultrasound Gel is manufactured by Quotient Medical.
What is the FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel?
The FDA product code for Sonishield 100 Antimicrobial Ultrasound Gel is MUI.
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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.