Home / 510(k) Clearances / K895791

510(k) K895791

OXYMAX by Columbus Instruments Intl. Corp. — Product Code BZL

K895791 is an FDA 510(k) premarket notification submitted by Columbus Instruments Intl. Corp. for the device "OXYMAX". The FDA issued a decision of Substantially Equivalent on March 28, 1990. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Columbus Instruments Intl. Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1990
Date Received
September 28, 1989
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 Columbus Instruments Intl. Corp.

  • K861543 — CARDIOMAX-II (March 10, 1987)
  • K861100 — ISO-THERMEX (May 12, 1986)
  • K782036 — TREMOR MONITOR (January 23, 1979)
  • K771718 — CARDIOTHERM-500X (September 28, 1977)

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