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510(k) K150810

Vyntus / SentrySuite Product Line by Carefusion Germany 234 GmbH — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2015
Date Received
March 26, 2015
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 Carefusion Germany 234 GmbH

  • K153654 — Sentry WEB SmartInterp (September 16, 2016)
  • K142959 — Vyntus Walk (March 20, 2015)
  • K141936 — MICROBLAB, MICROLOOP (December 29, 2014)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K122699 — SENTRYSUITE PRODUCT LINE (November 19, 2012)
  • K113813 — SENTRYSUITE PRODUCT LINE (May 10, 2012)
  • K113096 — MICRO I (April 13, 2012)
  • K111408 — MICROGARD II (October 17, 2011)
  • K111053 — SENTRYSUITE PRODUCT LINE (August 12, 2011)
  • K101873 — MASTERSCREEN IOS (February 10, 2011)

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)
  • K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE (August 22, 2014)
  • K133051 — PULMONE MINIBOX PFT TM (May 2, 2014)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)