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510(k) K854927

ICOR CALARIC MEASUREMENT UNIT (CMU) by Icor AB — Product Code BZL

K854927 is an FDA 510(k) premarket notification submitted by Icor AB for the device "ICOR CALARIC MEASUREMENT UNIT (CMU)". The FDA issued a decision of Substantially Equivalent on March 27, 1986. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Icor AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1986
Date Received
December 10, 1985
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 Icor AB

  • K954402 — ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (May 22, 1996)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K952325 — ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (July 31, 1995)
  • K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXR (July 13, 1995)
  • K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERS (August 15, 1994)
  • K940041 — COLIBRI (July 27, 1994)
  • K941436 — AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF (June 8, 1994)
  • K925622 — FHB, FHB-T, FHBFLEX, FHBFLEX-T (May 26, 1993)
  • K914416 — BREATH-EASY, MODIFICATION (June 23, 1992)
  • K904338 — ICOR HCH 4, ICOR HCH 7 (December 4, 1990)

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