FDA Product Code
FDA Product Code FIZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | 2020-09-02 | Special | PDF ↗ |
| K150657 | Phoenix XL Dialysate Meter | Mesa Laboratories, Inc. | 2015-09-21 | Traditional | PDF ↗ |
| K050812 | 90XL INSTRUMENTATION SYSTEM | Mesa Laboratories, Inc. | 2005-05-05 | Special | PDF ↗ |
| K020908 | HDM97 | Ibp Instruments GmbH | 2002-05-22 | Traditional | PDF ↗ |
| K020909 | HDM99 | Ibp Instruments GmbH | 2002-05-22 | Traditional | PDF ↗ |
| K992431 | NEO-2 METER | Automata Instrumentation, Inc. | 1999-10-13 | Traditional | PDF ↗ |
| K981294 | ODYSSEY INSTRUMENTATION SYSTEM | Automata Instrumentation, Inc. | 1998-07-08 | Traditional | PDF ↗ |
| K955298 | PHOENIX DIALYSATE METER | Automata Medical Instrumentation, Inc. | 1996-02-29 | Traditional | PDF ↗ |
| K920810 | NEO-STAT DIALYSATE METER | Automata Medical Instrumentation, Inc. | 1993-01-15 | Traditional | PDF ↗ |
| K881098 | MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER | Automata, Inc. | 1988-04-21 | Traditional | PDF ↗ |
| K871708 | NEO-I TEMPERATURE & CONDUCTIVITY METER | Automata, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K853735 | COLORADO MEDICAL MODEL CTM-3000 | Colorado Medical, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K780932 | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT | Western Laboratories Corp. | 1978-08-31 | Traditional | PDF ↗ |
Product code FIZ · Class II · Gastroenterology, Urology. Data: openFDA.