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510(k) K863087

SPIROLOOP-PULMONARY EXERCISE SYSTEM by Pneumedics, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1986
Date Received
August 12, 1986
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 Pneumedics, Inc.

  • K904633 — SPIROLOOP, MODIFICATION (March 12, 1991)
  • K894667 — MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP (October 19, 1989)

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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)