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510(k) K072735

PULSION PICCO-2, MODEL 8500 by Pulsion Medical Systems AG — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2007
Date Received
September 27, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Pulsion Medical Systems AG

  • K112448 — PULSIOFLEX (September 22, 2011)
  • K091786 — PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES ( (June 18, 2010)
  • K072364 — PULSION PULSIOCATH THERMODILUTION CATHETERS & ACCESSORIES (September 19, 2007)
  • K060898 — PULSION PICCO PLUS, MODEL 8100 (July 25, 2006)
  • K020587 — PULSION PULSIOCATH PICCO MONITORING KIT, INJECTATE SENSOR TEMPERATURE HOUSING PV (May 23, 2002)
  • K001762 — PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM (June 13, 2000)
  • K991886 — PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSO (May 11, 2000)

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