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FDA 510(k), K153023, Ablatherm Integrated Imaging
FDA 510(k), K153023, Ablatherm Integrated Imaging
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510(K) Number: K153023
Device Name: Ablatherm Integrated Imaging
Manufacturer: EDAP TECHNOMED, INC.
Device Classification Name: high intensity ultrasound system for prostate tissue ablation
Regulation Number: 876.4340
Classification Product Code: PLP
Date Received: 10/15/2015
Decision Date: 11/06/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Ablatherm Integrated Imaging
Manufacturer: EDAP TECHNOMED, INC.
Device Classification Name: high intensity ultrasound system for prostate tissue ablation
Regulation Number: 876.4340
Classification Product Code: PLP
Date Received: 10/15/2015
Decision Date: 11/06/2015
Regulation Medical Specialty: Gastroenterology/Urology
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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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