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: KXA
Date Received: 06/02/1999
Decision Date: 05/11/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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