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510(k) K051907

INNOCOR by Innovision A/S — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2006
Date Received
July 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Innovision A/S

  • K151146 — N-Force Fixation System (July 24, 2015)
  • K132244 — N-FORCE FIXATION SYSTEM (March 6, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)
  • K102528 — N-FORCE FIXATION SYSTEM (July 28, 2011)
  • K083879 — INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY- (February 23, 2009)
  • K071911 — CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR (September 7, 2007)
  • K011914 — HYDRO2, HS-75 (July 27, 2001)
  • K000485 — HYDRO2, HS-75 (May 12, 2000)
  • K944223 — ACCUCON (December 7, 1994)

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  • K251218 — SafeBeat Rx App (February 6, 2026)
  • K252164 — NorthStar™ Mapping System (January 28, 2026)
  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
  • K253733 — STAR Apollo™ Mapping System (December 19, 2025)
  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)