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FDA 510(k), K200136, Shear Wave Quantificational Ultrasound Diagnostic System
FDA 510(k), K200136, Shear Wave Quantificational Ultrasound Diagnostic System
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$149.00 USD
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510(K) Number: K200136
Device Name: Shear Wave Quantificational Ultrasound Diagnostic System
Manufacturer: Jinhua Shao
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: 01/21/2020
Date Received: 03/17/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Shear Wave Quantificational Ultrasound Diagnostic System
Manufacturer: Jinhua Shao
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: 01/21/2020
Date Received: 03/17/2020
Decision Date: Substantially Equivalent (SESE)
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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