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510(k) K021490

REEVUE INDIRECT CALORIMETER, MODEL#8100 by Korr Medical Technologies, Inc. — Product Code BZL

K021490 is an FDA 510(k) premarket notification submitted by Korr Medical Technologies, Inc. for the device "REEVUE INDIRECT CALORIMETER, MODEL#8100". The FDA issued a decision of Substantially Equivalent on January 2, 2003. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Korr Medical Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2003
Date Received
May 9, 2002
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 Korr Medical Technologies, Inc.

  • K982995 — ACCUTRAX, MODEL EPF840 (December 4, 1998)

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)
  • K021605 — MEDGEM (June 14, 2002)
  • K010577 — BODYGEM, MODEL HB211 (January 10, 2002)
  • K954731 — OXYLOG 2 (January 6, 1997)

FDA data resources