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FDA 510(k)

Ultra/Phonic Scanning Gel

K-Number: K163026 · 2018-01-09

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

Device Summary

Ultra/Phonic Scanning Gel is a medical device manufactured by Pharmaceutical Innovations, Inc.. It received FDA 510(k) clearance on 2018-01-09 under approval number K163026. 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 Scanning Gel?

Ultra/Phonic Scanning Gel is a medical device that received FDA 510(k) clearance on 2018-01-09. It is manufactured by Pharmaceutical Innovations, Inc.. The 510(k) number is K163026.

When was Ultra/Phonic Scanning Gel approved by the FDA?

Ultra/Phonic Scanning Gel received FDA 510(k) clearance on 2018-01-09, under approval number K163026.

What company makes Ultra/Phonic Scanning Gel?

Ultra/Phonic Scanning Gel is manufactured by Pharmaceutical Innovations, Inc..

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

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

Other Devices by Pharmaceutical Innovations, Inc.

K163027Ultra/Phonic Free Conductivity Gel K163024Ultra/Phonic Conductivity Gel K163023Other-Sonic Transmission Gel

Related Devices (Code: MUI)

K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical K163050Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc. K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc. K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc. K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc. K163023Other-Sonic Transmission GelPharmaceutical Innovations, Inc.

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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