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510(k) K920810

NEO-STAT DIALYSATE METER by Automata Medical Instrumentation, Inc. — Product Code FIZ

K920810 is an FDA 510(k) premarket notification submitted by Automata Medical Instrumentation, Inc. for the device "NEO-STAT DIALYSATE METER". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code FIZ (Meter, Conductivity, Non-Remote), a Class II device regulated under 21 CFR 876.5820. Automata Medical Instrumentation, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1993
Date Received
February 21, 1992
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 Automata Medical Instrumentation, Inc.

  • K955298 — PHOENIX DIALYSATE METER (February 29, 1996)

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)
  • K881098 — MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER (April 21, 1988)
  • K871708 — NEO-I TEMPERATURE & CONDUCTIVITY METER (June 17, 1987)

FDA data resources