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510(k) K221030

Model 9100 PFT/DICO by Vitalograph Ireland, Ltd. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2022
Date Received
April 7, 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 by Vitalograph Ireland, Ltd.

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Other clearances for product code BTY

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  • K222982 — Virtus Metabolic Monitor (June 23, 2023)
  • 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)