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FDA 510(k), K163253, Arterys Cardio DL
FDA 510(k), K163253, Arterys Cardio DL
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$49.00 USD
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510(K) Number: K163253
Device Name: Arterys Cardio DL
Manufacturer: ARTERYS INC.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 11/18/2016
Decision Date: 01/05/2017
Regulation Medical Specialty: Radiology
Device Name: Arterys Cardio DL
Manufacturer: ARTERYS INC.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 11/18/2016
Decision Date: 01/05/2017
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
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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