Product Code: FIZ FDA class 2 21 CFR 876.5820

Meter, Conductivity, Non-Remote

Gastroenterology, Urology

The Non-Remote Conductivity Meter is an instrument used in hemodialysis to measure the ionic conductivity of dialysate solution at the point of use, verifying that the dialysate concentration is within safe and therapeutic limits. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FIZ, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.

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510(k)s

FEI Numbers

Registration Numbers

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Years Active

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Basic Information

Product Code: FIZ
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K201765	SmartHDM-510 System	Sep 02, 2020	Substantially Equivalent	Mesa Laboratories, Inc.
K150657	Phoenix XL Dialysate Meter	Sep 21, 2015	Substantially Equivalent	Mesa Laboratories, Inc.
K050812	90XL INSTRUMENTATION SYSTEM	May 05, 2005	Substantially Equivalent	Mesa Laboratories, Inc.
K020909	HDM99	May 22, 2002	Substantially Equivalent	Ibp Instruments GmbH
K020908	HDM97	May 22, 2002	Substantially Equivalent	Ibp Instruments GmbH
K992431	NEO-2 METER	Oct 13, 1999	Substantially Equivalent	Automata Instrumentation, Inc.
K981294	ODYSSEY INSTRUMENTATION SYSTEM	Jul 08, 1998	Substantially Equivalent	Automata Instrumentation, Inc.
K955298	PHOENIX DIALYSATE METER	Feb 29, 1996	Substantially Equivalent	Automata Medical Instrumentation, Inc.
K920810	NEO-STAT DIALYSATE METER	Jan 15, 1993	Substantially Equivalent	Automata Medical Instrumentation, Inc.
K881098	MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER	Apr 21, 1988	Substantially Equivalent	Automata, Inc.
K871708	NEO-I TEMPERATURE & CONDUCTIVITY METER	Jun 17, 1987	Substantially Equivalent	Automata, Inc.
K853735	COLORADO MEDICAL MODEL CTM-3000	Oct 04, 1985	Substantially Equivalent	Colorado Medical, Inc.
K780932	MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT	Aug 31, 1978	Substantially Equivalent	Western Laboratories Corp.