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510(k) K050812

90XL INSTRUMENTATION SYSTEM by Mesa Laboratories, Inc. — Product Code FIZ

K050812 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "90XL INSTRUMENTATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 5, 2005. The device falls under product code FIZ (Meter, Conductivity, Non-Remote), a Class II device regulated under 21 CFR 876.5820. Mesa Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 2005
Date Received
March 31, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Conductivity, Non-Remote
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Mesa Laboratories, Inc.

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K191496 — TDS Standard Solution (August 5, 2019)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K140589 — STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR (December 3, 2014)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K122362 — SMART-WELL INCUBATOR (March 26, 2013)
  • K112018 — SMART READ EZTEST STEAM (January 30, 2012)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)

Other clearances for product code FIZ

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K020908 — HDM97 (May 22, 2002)
  • K020909 — HDM99 (May 22, 2002)
  • K992431 — NEO-2 METER (October 13, 1999)
  • K981294 — ODYSSEY INSTRUMENTATION SYSTEM (July 8, 1998)
  • K955298 — PHOENIX DIALYSATE METER (February 29, 1996)
  • K920810 — NEO-STAT DIALYSATE METER (January 15, 1993)
  • K881098 — MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER (April 21, 1988)
  • K871708 — NEO-I TEMPERATURE & CONDUCTIVITY METER (June 17, 1987)

FDA data resources