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510(k) K201765

SmartHDM-510 System by Mesa Laboratories, Inc. — Product Code FIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2020
Date Received
June 29, 2020
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.

  • 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)
  • K050812 — 90XL INSTRUMENTATION SYSTEM (May 5, 2005)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)

Other clearances for product code FIZ

  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • K050812 — 90XL INSTRUMENTATION SYSTEM (May 5, 2005)
  • 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)