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510(k) K780932

MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT by Western Laboratories Corp. — Product Code FIZ

K780932 is an FDA 510(k) premarket notification submitted by Western Laboratories Corp. for the device "MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code FIZ (Meter, Conductivity, Non-Remote), a Class II device regulated under 21 CFR 876.5820. Western Laboratories Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
June 6, 1978
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 Western Laboratories Corp.

  • K834024 — HEPARINOMETER (June 11, 1984)
  • K830468 — MODEL 200 (April 12, 1983)
  • K821834 — MODEL 100 BICARBONATE CONDUCTIVITY (July 2, 1982)
  • K821414 — MODEL 80 BC (May 27, 1982)
  • K821415 — MODEL 90 BC (May 27, 1982)
  • K801303 — MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST (July 28, 1980)

Other clearances for product code FIZ

  • K201765 — SmartHDM-510 System (September 2, 2020)
  • K150657 — Phoenix XL Dialysate Meter (September 21, 2015)
  • 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)

FDA data resources