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FDA 510(k), K100989, ZURA TEE SYSTEM WITH CLARITEE PROBE
FDA 510(k), K100989, ZURA TEE SYSTEM WITH CLARITEE PROBE
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510(K) Number: K100989
Device Name: ZURA TEE SYSTEM WITH CLARITEE PROBE
Manufacturer: RICHARD LANZILLOTTO
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: IYN
Classification Product Code: KXA
Date Received: 04/09/2010
Decision Date: 06/25/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ZURA TEE SYSTEM WITH CLARITEE PROBE
Manufacturer: RICHARD LANZILLOTTO
Device Classification Name: System, Imaging, Pulsed Doppler, Ultrasonic
Regulation Number: IYN
Classification Product Code: KXA
Date Received: 04/09/2010
Decision Date: 06/25/2010
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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