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510(k) K013943

RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 by Radi Medical Systems AB — Product Code DSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2001
Date Received
November 29, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

Other clearances by Radi Medical Systems AB

  • K123984 — QUANTIEN MEASUREMENT SYSTEM (March 28, 2013)
  • K092105 — RADIANALYZER XPRESS (October 9, 2009)
  • K080813 — PRESSUREWIRE CERTUS, CERTUS (300CM), AERIS, AERIS (300CM), RECEIVER (July 1, 2008)
  • K080206 — MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM (February 26, 2008)
  • K062769 — PRESSUREWIRE CERTUS, MODELS 12006 AND 12306 (December 4, 2006)
  • K042628 — MODIFICATION TO: RADIANALYZER, MODEL 12711 (January 19, 2005)
  • K033291 — TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 (March 17, 2004)
  • K031662 — PRESSURE WIRE SENSOR, MODELS 12004/12304 (June 6, 2003)
  • K024107 — FEMOSTOP FEMORAL COMPRESSION SYSTEM (December 24, 2002)
  • K022188 — RADIANALYZER, MODEL 12710 (October 3, 2002)

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  • K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box (December 3, 2015)
  • K141615 — ENDOPHYS BLOOD PRESSURE MONITOR (January 7, 2015)
  • K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (April 23, 2008)
  • K070795 — SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM (August 31, 2007)
  • K033738 — MONITORING SYSTEM, MODEL ARGUS PB-2200 (August 24, 2004)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K011865 — ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION (July 31, 2001)
  • K003122 — SMARTFLOW, MODEL SFIP 2000 (May 14, 2001)