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FDA 510(k), K210541, ulrichINJECT CT motion
FDA 510(k), K210541, ulrichINJECT CT motion
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510(K) Number: K210541
Device Name: ulrichINJECT CT motion
Manufacturer: Sven Erdmann
Device Classification Name: Injector, Contrast Medium, Automatic
Regulation Number: IZQ
Classification Product Code: KXA
Date Received: 02/24/2021
Decision Date: 08/06/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: ulrichINJECT CT motion
Manufacturer: Sven Erdmann
Device Classification Name: Injector, Contrast Medium, Automatic
Regulation Number: IZQ
Classification Product Code: KXA
Date Received: 02/24/2021
Decision Date: 08/06/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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