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FDA 510(k), K192154, Rio Vial-to-Bag Drug Reconstitution Device
FDA 510(k), K192154, Rio Vial-to-Bag Drug Reconstitution Device
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510(K) Number: K192154
Device Name: Rio Vial-to-Bag Drug Reconstitution Device
Manufacturer: Sheila Antonio
Device Classification Name: Set, I.V. Fluid Transfer
Regulation Number: LHI
Classification Product Code: 08/09/2019
Date Received: 04/20/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: Rio Vial-to-Bag Drug Reconstitution Device
Manufacturer: Sheila Antonio
Device Classification Name: Set, I.V. Fluid Transfer
Regulation Number: LHI
Classification Product Code: 08/09/2019
Date Received: 04/20/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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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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