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510(k) K820475

MGC/LITTON 2300 by Medical Graphics Corp. — Product Code BZL

K820475 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "MGC/LITTON 2300". The FDA issued a decision of Substantially Equivalent on March 23, 1982. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1982
Date Received
February 19, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Oxygen-Uptake
Device Class
Class II
Regulation Number
868.1730
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 BZL

  • K200076 — Breezing Med (September 25, 2020)
  • K190561 — NICU V'02 (September 4, 2020)
  • K110810 — ANASCIENT BREATH MONITOR (June 21, 2011)
  • K093080 — METAPHOR METABOLIC MONITOR (January 22, 2010)
  • K071533 — FITMATE SERIES (September 28, 2007)
  • K070858 — EXPRESS SERIES (April 16, 2007)
  • K061731 — MEDGRAPHICS ULTIMA SYSTEM (September 6, 2006)
  • K021490 — REEVUE INDIRECT CALORIMETER, MODEL#8100 (January 2, 2003)
  • K021605 — MEDGEM (June 14, 2002)
  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)

FDA data resources