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510(k) K871708

NEO-I TEMPERATURE & CONDUCTIVITY METER by Automata, Inc. — Product Code FIZ

K871708 is an FDA 510(k) premarket notification submitted by Automata, Inc. for the device "NEO-I TEMPERATURE & CONDUCTIVITY METER". The FDA issued a decision of Substantially Equivalent on June 17, 1987. The device falls under product code FIZ (Meter, Conductivity, Non-Remote), a Class II device regulated under 21 CFR 876.5820. Automata, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1987
Date Received
May 1, 1987
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, Inc.

  • K881098 — MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER (April 21, 1988)

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