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FDA 510(k), K141620, RS80A DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k), K141620, RS80A DIAGNOSTIC ULTRASOUND SYSTEM
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510(K) Number: K141620
Device Name: RS80A DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer: SAMSUNG MEDISON CO., LTD
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 06/17/2014
Decision Date: 07/02/2014
Regulation Medical Specialty: Radiology
Device Name: RS80A DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer: SAMSUNG MEDISON CO., LTD
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 06/17/2014
Decision Date: 07/02/2014
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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