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510(k) K150657

Phoenix XL Dialysate Meter by Mesa Laboratories, Inc. — Product Code FIZ

K150657 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "Phoenix XL Dialysate Meter". The FDA issued a decision of Substantially Equivalent on September 21, 2015. 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
September 21, 2015
Date Received
March 13, 2015
Clearance Type
Traditional
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)
  • 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

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K050812 — 90XL INSTRUMENTATION SYSTEM (May 5, 2005)
  • K020909 — HDM99 (May 22, 2002)
  • K020908 — HDM97 (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