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FDA 510(k), K122121, PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
FDA 510(k), K122121, PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
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510(K) Number: K122121
Device Name: PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
Manufacturer: PULSION MEDICAL SYSTEMS SE
Device Classification Name: computer, diagnostic, pre-programmed, single-function
Regulation Number: 870.1435
Classification Product Code: DXG
Date Received: 07/17/2012
Decision Date: 08/02/2012
Regulation Medical Specialty: Cardiovascular
Device Name: PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE
Manufacturer: PULSION MEDICAL SYSTEMS SE
Device Classification Name: computer, diagnostic, pre-programmed, single-function
Regulation Number: 870.1435
Classification Product Code: DXG
Date Received: 07/17/2012
Decision Date: 08/02/2012
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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