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510(k) K923209

MEDGRAPHICS EXERCISE CONSULT by Medical Graphics Corp. — Product Code BZM

K923209 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "MEDGRAPHICS EXERCISE CONSULT". The FDA issued a decision of Substantially Equivalent on March 11, 1993. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1993
Date Received
July 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
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)
  • 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)
  • K871711 — MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM (September 25, 1987)

Other clearances for product code BZM

  • K102229 — PULMOTRACK 2020 SYSTEM (March 4, 2011)
  • K090863 — PERSONAL WHEEZOMETER (September 21, 2009)
  • K071955 — WIM-PC, MODEL 1010 (November 1, 2007)
  • K012387 — STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM (April 23, 2002)
  • K980878 — PULMOTRACK,MODEL 1010 (December 28, 1998)
  • K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (July 21, 1998)
  • K955432 — CPX, CCM, CATH WITH 15% CO2 (July 1, 1996)
  • K911143 — PB100 DIAGNOSTIC SPIROMETER (November 29, 1991)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)
  • K880550 — BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (July 25, 1988)

FDA data resources