FDA 510(k), K160524, FibroScan 530 Compact
FDA 510(k), K160524, FibroScan 530 Compact
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510(K) Number: K160524
Device Name: FibroScan 530 Compact
Manufacturer: ECHOSENS
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 02/25/2016
Decision Date: 03/18/2016
Regulation Medical Specialty: Radiology
Device Name: FibroScan 530 Compact
Manufacturer: ECHOSENS
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 02/25/2016
Decision Date: 03/18/2016
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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