FIZ
13 FDA 510(k) clearances · Product code
65 daysmedian time to decision
192 days90th percentile
13clearances measured
FDA profile
- Official device name
- Meter, Conductivity, Non-Remote
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SmartHDM-510 System (K201765) | Mesa Laboratories, Inc. | 2020-09-02 |
| Phoenix XL Dialysate Meter (K150657) | Mesa Laboratories, Inc. | 2015-09-21 |
| 90XL INSTRUMENTATION SYSTEM (K050812) | Mesa Laboratories, Inc. | 2005-05-05 |
| HDM97 (K020908) | Ibp Instruments GmbH | 2002-05-22 |
| HDM99 (K020909) | Ibp Instruments GmbH | 2002-05-22 |
| NEO-2 METER (K992431) | Automata Instrumentation, Inc. | 1999-10-13 |
| ODYSSEY INSTRUMENTATION SYSTEM (K981294) | Automata Instrumentation, Inc. | 1998-07-08 |
| PHOENIX DIALYSATE METER (K955298) | Automata Medical Instrumentation, Inc. | 1996-02-29 |
| NEO-STAT DIALYSATE METER (K920810) | Automata Medical Instrumentation, Inc. | 1993-01-15 |
| MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER (K881098) | Automata, Inc. | 1988-04-21 |
| NEO-I TEMPERATURE & CONDUCTIVITY METER (K871708) | Automata, Inc. | 1987-06-17 |
| COLORADO MEDICAL MODEL CTM-3000 (K853735) | Colorado Medical, Inc. | 1985-10-04 |
| MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT (K780932) | Western Laboratories Corp. | 1978-08-31 |
Track FIZ automatically
Every clearance here is in the API, with alerts when new ones post.