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510(k) K850045

SPIROMETRICS 2453 & SMI III by Spirometrics, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1985
Date Received
January 7, 1985
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 Spirometrics, Inc.

  • K915059 — PEAK FLOW MONITOR (July 27, 1992)
  • K911358 — CMD/DLCO DIAGNOSTIC SPIROMETER (July 22, 1991)
  • K900322 — CO/CMD-1 (April 30, 1990)
  • K901057 — SPIROMETRICS MODEL 2600 MIRO SPIROMETER (April 3, 1990)
  • K900673 — SERIAL FLOW (April 3, 1990)
  • K884464 — SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR (January 19, 1989)
  • K884465 — SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM) (November 9, 1988)
  • K863953 — SPIROMETRICS MODEL 2500 FLOWMATE(TM) (January 15, 1987)
  • K844333 — SPIROMETRICS 2451 & SMI I (November 20, 1984)
  • K831497 — SPIROMETRICS BREON 2400 & SMI 2400 (June 24, 1983)

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)
  • 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)