Product code FIZ— Gastroenterology, Urology

FDA has cleared 13 devices under product code FIZ between 1978 and 2020, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20201 clearance
• 20151 clearance
• 20051 clearance
• 20022 clearances
• 19991 clearance
• 19981 clearance
• 19961 clearance
• 19931 clearance
• 19881 clearance
• 19871 clearance
• 19851 clearance
• 19781 clearance

• Mesa Laboratories, Inc.3 clearances
• Ibp Instruments GmbH2 clearances
• Automata Medical Instrumentation, Inc.2 clearances
• Automata Instrumentation, Inc.2 clearances
• Automata, Inc.2 clearances
• Western Laboratories Corp.1 clearance
• Colorado Medical, Inc.1 clearance

• K201765 — SmartHDM-510 SystemMesa Laboratories, Inc.·2020-09-02
• K150657 — Phoenix XL Dialysate MeterMesa Laboratories, Inc.·2015-09-21
• K050812 — 90XL INSTRUMENTATION SYSTEMMesa Laboratories, Inc.·2005-05-05
• K020908 — HDM97Ibp Instruments GmbH·2002-05-22
• K020909 — HDM99Ibp Instruments GmbH·2002-05-22
• K992431 — NEO-2 METERAutomata Instrumentation, Inc.·1999-10-13
• K981294 — ODYSSEY INSTRUMENTATION SYSTEMAutomata Instrumentation, Inc.·1998-07-08
• K955298 — PHOENIX DIALYSATE METERAutomata Medical Instrumentation, Inc.·1996-02-29
• K920810 — NEO-STAT DIALYSATE METERAutomata Medical Instrumentation, Inc.·1993-01-15
• K881098 — MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METERAutomata, Inc.·1988-04-21
• K871708 — NEO-I TEMPERATURE & CONDUCTIVITY METERAutomata, Inc.·1987-06-17
• K853735 — COLORADO MEDICAL MODEL CTM-3000Colorado Medical, Inc.·1985-10-04
• K780932 — MODEL 80 CONDUCTIVITY/TEMP.TEST UNITWestern Laboratories Corp.·1978-08-31