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510(k) K111053

SENTRYSUITE PRODUCT LINE by Carefusion Germany 234 GmbH — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2011
Date Received
April 15, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Carefusion Germany 234 GmbH

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  • K150810 — Vyntus / SentrySuite Product Line (August 14, 2015)
  • 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)
  • K101873 — MASTERSCREEN IOS (February 10, 2011)

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  • K231561 — Pulmonary Function Tester, Model: A9 (February 21, 2024)
  • K222982 — Virtus Metabolic Monitor (June 23, 2023)
  • K221030 — Model 9100 PFT/DICO (July 15, 2022)
  • K202754 — MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (January 28, 2021)
  • K190800 — Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (February 6, 2020)
  • K181912 — Ascent Cardiorespiratory Diagnostic Software (April 12, 2019)
  • K173937 — SpiroSphere (February 15, 2019)
  • K161534 — EasyOne Pro Respiratory Analysis System (February 22, 2017)