Home / 510(k) Clearances / K222982

510(k) K222982

Virtus Metabolic Monitor by Virtus Technology Aps — Product Code BTY

K222982 is an FDA 510(k) premarket notification submitted by Virtus Technology Aps for the device "Virtus Metabolic Monitor". The FDA issued a decision of Substantially Equivalent on June 23, 2023. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
September 28, 2022
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 for product code BTY

  • K242809 — Ascent Cardiorespiratory Diagnostic Software (October 17, 2024)
  • K223629 — SpiroSphere, SpiroSphereECG, CardioSphere (May 28, 2024)
  • K231561 — Pulmonary Function Tester, Model: A9 (February 21, 2024)
  • 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)
  • K150888 — Shape-HF Cardiopulmonary Testing System (January 21, 2016)

FDA data resources