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510(k) K102047

LCI OPTION FOR INNOCOR by Innovision A/S — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2011
Date Received
July 21, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Data
Device Class
Class II
Regulation Number
868.1880
Review Panel
AN
Submission Type

Other clearances by Innovision A/S

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  • K083879 — INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY- (February 23, 2009)
  • K071911 — CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR (September 7, 2007)
  • K051907 — INNOCOR (March 2, 2006)
  • K011914 — HYDRO2, HS-75 (July 27, 2001)
  • K000485 — HYDRO2, HS-75 (May 12, 2000)
  • K944223 — ACCUCON (December 7, 1994)

Other clearances for product code BZC

  • K240293 — STS (September 17, 2024)
  • K183567 — Vyntus/SentrySuite Product Line (August 23, 2019)
  • K190853 — Vyntus BODY (August 16, 2019)
  • K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable (November 30, 2018)
  • K162515 — COSMED K5 Wearable Metabolic Technology (June 20, 2017)
  • K161295 — MiniBox + (October 21, 2016)
  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)