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FDA 510(k), K191645, SKR 4000
FDA 510(k), K191645, SKR 4000
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510(K) Number: K191645
Device Name: SKR 4000
Manufacturer: Tsutomu Fukui
Device Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Number: MQB
Classification Product Code: KXA
Date Received: 06/19/2019
Decision Date: 08/16/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SKR 4000
Manufacturer: Tsutomu Fukui
Device Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Number: MQB
Classification Product Code: KXA
Date Received: 06/19/2019
Decision Date: 08/16/2019
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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