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FDA 510(k), K163026, Ultra/Phonic Scanning Gel
FDA 510(k), K163026, Ultra/Phonic Scanning Gel
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510(K) Number: K163026
Device Name: Ultra/Phonic Scanning Gel
Manufacturer: Pharmaceutical Innovations Inc.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 10/31/2016
Decision Date: 01/09/2018
Regulation Medical Specialty: Radiology
Device Name: Ultra/Phonic Scanning Gel
Manufacturer: Pharmaceutical Innovations Inc.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 10/31/2016
Decision Date: 01/09/2018
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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