Home / 510(k) Clearances / K861486

510(k) K861486

SPIROMETRY MODULE by Medical Graphics Corp. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1986
Date Received
April 22, 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 Medical Graphics Corp.

  • K152585 — Resmon PRO FULL (June 24, 2016)
  • K070858 — EXPRESS SERIES (April 16, 2007)
  • K061731 — MEDGRAPHICS ULTIMA SYSTEM (September 6, 2006)
  • K955432 — CPX, CCM, CATH WITH 15% CO2 (July 1, 1996)
  • K943259 — 1085 ULTIMATE E PLETHYSMOGRAPH (April 10, 1995)
  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K912906 — MEDGRAPHICS PF/DX (February 4, 1992)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)
  • K896396 — MIDA SYSTEM, MODELS 1000/1100 (January 18, 1990)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)

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)