Home / 510(k) Clearances / K183567

510(k) K183567

Vyntus/SentrySuite Product Line by Vyaire Medical — Product Code BZC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2019
Date Received
December 21, 2018
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 Vyaire Medical

  • K230915 — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (November 12, 2024)
  • K231380 — AirLife DuoTherm™ Humidification System (August 10, 2023)
  • K201082 — LTV2 Series Ventilators (November 10, 2021)
  • K211294 — Multi-Link X2 ECG Cable and Leadwire System (August 16, 2021)
  • K200510 — Multi-LinkTM X2 ECG Adapter and Leadwires (October 9, 2020)
  • K191273 — Multi-Link X2 ECG and SpO2 Adapter (September 13, 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)
  • K171678 — Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, (April 30, 2018)
  • K170378 — AirLife Adult Heated Wire BiPAP/NIV Circuit (September 14, 2017)

Other clearances for product code BZC

  • K240293 — STS (September 17, 2024)
  • 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)
  • K102047 — LCI OPTION FOR INNOCOR (November 1, 2011)
  • K072323 — MASTERSCREEN & OXYCON CPX (October 10, 2007)