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FDA 510(k), K200717, CLEWICU System (ClewICUServer and ClewICUnitor)
FDA 510(k), K200717, CLEWICU System (ClewICUServer and ClewICUnitor)
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510(K) Number: K200717
Device Name: CLEWICU System (ClewICUServer and ClewICUnitor)
Manufacturer: CLEW Medical Ltd.
Device Classification Name: medium-term adjunctive predictive cardiovascular indicator
Regulation Number: 870.2210
Classification Product Code: QNL
Date Received: 03/18/2020
Decision Date: 01/09/2021
Regulation Medical Specialty: Cardiovascular
Device Name: CLEWICU System (ClewICUServer and ClewICUnitor)
Manufacturer: CLEW Medical Ltd.
Device Classification Name: medium-term adjunctive predictive cardiovascular indicator
Regulation Number: 870.2210
Classification Product Code: QNL
Date Received: 03/18/2020
Decision Date: 01/09/2021
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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