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FDA 510(k), K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels
FDA 510(k), K181363, EcoVue Sterile and Non-Sterile Ultrasound Gels
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510(K) Number: K181363
Device Name: EcoVue Sterile and Non-Sterile Ultrasound Gels
Manufacturer: HR Pharmaceuticals, Inc.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 05/23/2018
Decision Date: 06/13/2018
Regulation Medical Specialty: Radiology
Device Name: EcoVue Sterile and Non-Sterile Ultrasound Gels
Manufacturer: HR Pharmaceuticals, Inc.
Device Classification Name: Media, Coupling, Ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 05/23/2018
Decision Date: 06/13/2018
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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