FDA 510(k), K183575, ACUSON S3000, S2000 Diagnostic Ultrasound System
FDA 510(k), K183575, ACUSON S3000, S2000 Diagnostic Ultrasound System
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510(K) Number: K183575
Device Name: ACUSON S3000, S2000 Diagnostic Ultrasound System
Manufacturer: Christine Dunbar
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: IYN
Classification Product Code: 12/21/2018
Date Received: 03/20/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ACUSON S3000, S2000 Diagnostic Ultrasound System
Manufacturer: Christine Dunbar
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: IYN
Classification Product Code: 12/21/2018
Date Received: 03/20/2019
Decision Date: Substantially Equivalent (SESE)
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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