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FDA 510(k), K192109, KOALA
FDA 510(k), K192109, KOALA
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510(K) Number: K192109
Device Name: KOALA
Manufacturer: IB Lab GmbH
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/05/2019
Decision Date: 11/05/2019
Regulation Medical Specialty: Radiology
Device Name: KOALA
Manufacturer: IB Lab GmbH
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/05/2019
Decision Date: 11/05/2019
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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