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510(k) K823695

CPM METABOLIC MONITOR by Medicor USA , Ltd. — Product Code BZL

K823695 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "CPM METABOLIC MONITOR". The FDA issued a decision of Substantially Equivalent on January 14, 1983. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1983
Date Received
December 8, 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 Medicor USA , Ltd.

  • K861994 — MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM (July 18, 1986)
  • K861995 — MODEL RS-3 RADIOGRAPHIC STAND (June 19, 1986)
  • K860025 — MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR (May 7, 1986)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER (July 1, 1985)
  • K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER (June 19, 1985)
  • K843335 — FLOOR MOUNTED X-RAY TUBESTAND (November 27, 1984)
  • K840227 — UROLIX-3 UROLOGICAL TABLE (March 23, 1984)
  • K840225 — C-ARM CEILING CRANE FT-2 (March 22, 1984)
  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)

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