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FDA 510(k), K080223, ZURA TEE SYSTEM
FDA 510(k), K080223, ZURA TEE SYSTEM
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510(K) Number: K080223
Device Name: ZURA TEE SYSTEM
Manufacturer: STEVEN B DATLOF M.D., J.D.
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: 01/29/2008
Date Received: 06/24/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ZURA TEE SYSTEM
Manufacturer: STEVEN B DATLOF M.D., J.D.
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: 01/29/2008
Date Received: 06/24/2008
Decision Date: Substantially Equivalent (SESE)
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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