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FDA 510(k), K112997, HD-IVUS ULTRASOUND IMAGING SYSTEM
FDA 510(k), K112997, HD-IVUS ULTRASOUND IMAGING SYSTEM
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510(K) Number: K112997
Device Name: HD-IVUS ULTRASOUND IMAGING SYSTEM
Manufacturer: SILICON VALLY MEDICAL INSTRUMENTS, INC.
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 10/07/2011
Decision Date: 12/17/2011
Regulation Medical Specialty: Radiology
Device Name: HD-IVUS ULTRASOUND IMAGING SYSTEM
Manufacturer: SILICON VALLY MEDICAL INSTRUMENTS, INC.
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 10/07/2011
Decision Date: 12/17/2011
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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