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FDA 510(k), K150949, FibroScan
FDA 510(k), K150949, FibroScan
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510(K) Number: K150949
Device Name: FibroScan
Manufacturer: ECHOSENS
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 04/08/2015
Decision Date: 06/03/2015
Regulation Medical Specialty: Radiology
Device Name: FibroScan
Manufacturer: ECHOSENS
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 04/08/2015
Decision Date: 06/03/2015
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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