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FDA 510(k), K042566, VASC-ALERT
FDA 510(k), K042566, VASC-ALERT
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510(K) Number: K042566
Device Name: VASC-ALERT
Manufacturer: JOHN B KENNEDY
Device Classification Name: System, Hemodialysis, Access Recirculation Monitoring
Regulation Number: MQS
Classification Product Code: 09/21/2004
Date Received: 11/08/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: VASC-ALERT
Manufacturer: JOHN B KENNEDY
Device Classification Name: System, Hemodialysis, Access Recirculation Monitoring
Regulation Number: MQS
Classification Product Code: 09/21/2004
Date Received: 11/08/2004
Decision Date: Substantially Equivalent (SESE)
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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