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FDA 510(k), K984058, ACIST INJECTOR SYSTEM, MODEL CL100 H
FDA 510(k), K984058, ACIST INJECTOR SYSTEM, MODEL CL100 H
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510(K) Number: K984058
Device Name: ACIST INJECTOR SYSTEM, MODEL CL100 H
Manufacturer: ACIST MEDICAL SYSTEMS
Device Classification Name: injector, contrast medium, automatic
Regulation Number: 870.1650
Classification Product Code: IZQ
Date Received: 11/13/1998
Decision Date: 02/11/1999
Regulation Medical Specialty: Cardiovascular
Device Name: ACIST INJECTOR SYSTEM, MODEL CL100 H
Manufacturer: ACIST MEDICAL SYSTEMS
Device Classification Name: injector, contrast medium, automatic
Regulation Number: 870.1650
Classification Product Code: IZQ
Date Received: 11/13/1998
Decision Date: 02/11/1999
Regulation Medical Specialty: Cardiovascular
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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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