FDA 510(k), K991886, PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
FDA 510(k), K991886, PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
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510(K) Number: K991886
Device Name: PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
Manufacturer: ULF BORG
Device Classification Name: Probe, Thermodilution
Regulation Number: KRB
Classification Product Code: 06/02/1999
Date Received: 05/11/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR
Manufacturer: ULF BORG
Device Classification Name: Probe, Thermodilution
Regulation Number: KRB
Classification Product Code: 06/02/1999
Date Received: 05/11/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
- 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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