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510(k) K801852

MRM-2 OXYGEN CONSUMPTION MONITOR by Waters Assoc., Inc. — Product Code BZL

K801852 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "MRM-2 OXYGEN CONSUMPTION MONITOR". The FDA issued a decision of Substantially Equivalent on August 20, 1980. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
August 4, 1980
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 Waters Assoc., Inc.

  • K811975 — MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL (July 27, 1981)
  • K802481 — 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH (October 31, 1980)
  • K801431 — PAN-AM MYELOGRAM TRAY (August 12, 1980)
  • K791661 — SYSTEM CONTROLLER 720 SERIES (September 24, 1979)
  • K791026 — 4F STERILE BALLOON-LESS, CATHETER 913-28 (June 22, 1979)
  • K782175 — CARTRIDGE HOLDER, RCM 100 (February 15, 1979)
  • K790145 — SOLVENT DELIVERY SYSTEM (February 15, 1979)
  • K781805 — CARDIAC COMPUTERS, CO-10 & CO-10R (January 29, 1979)
  • K781915 — DATA MODULE (January 10, 1979)
  • K781692 — CALIBRATOR, DYNAMIC (November 29, 1978)

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