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FDA 510(k), K163334, LiDCOunity v2 Hemodynamic Monitor
FDA 510(k), K163334, LiDCOunity v2 Hemodynamic Monitor
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510(K) Number: K163334
Device Name: LiDCOunity v2 Hemodynamic Monitor
Manufacturer: LiDCO Ltd
Device Classification Name: computer, diagnostic, pre-programmed, single-function
Regulation Number: 870.1435
Classification Product Code: DXG
Date Received: 11/28/2016
Decision Date: 06/05/2017
Regulation Medical Specialty: Cardiovascular
Device Name: LiDCOunity v2 Hemodynamic Monitor
Manufacturer: LiDCO Ltd
Device Classification Name: computer, diagnostic, pre-programmed, single-function
Regulation Number: 870.1435
Classification Product Code: DXG
Date Received: 11/28/2016
Decision Date: 06/05/2017
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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