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510(k) K223629

SpiroSphere, SpiroSphereECG, CardioSphere by Eresearchtechnology GmbH — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2024
Date Received
December 5, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Eresearchtechnology GmbH

  • K202754 — MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (January 28, 2021)
  • K173937 — SpiroSphere (February 15, 2019)

Other clearances for product code BTY

  • K242809 — Ascent Cardiorespiratory Diagnostic Software (October 17, 2024)
  • 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)
  • K150888 — Shape-HF Cardiopulmonary Testing System (January 21, 2016)