FDA 510(k), K151070, Sonishield 100 Antimicrobial Ultrasound Gel
FDA 510(k), K151070, Sonishield 100 Antimicrobial Ultrasound Gel
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510(K) Number: K151070
Device Name: Sonishield 100 Antimicrobial Ultrasound Gel
Manufacturer: Quotient Medical
Device Classification Name: media, coupling, ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 04/21/2015
Decision Date: 01/13/2016
Regulation Medical Specialty: Radiology
Device Name: Sonishield 100 Antimicrobial Ultrasound Gel
Manufacturer: Quotient Medical
Device Classification Name: media, coupling, ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 04/21/2015
Decision Date: 01/13/2016
Regulation Medical Specialty: Radiology
- 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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