FIZ — Meter, Conductivity, Non-Remote Class II
FDA product code FIZ covers "Meter, Conductivity, Non-Remote", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FIZ
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201765 | mesa laboratories | SmartHDM-510 System | September 2, 2020 |
| K150657 | mesa laboratories | Phoenix XL Dialysate Meter | September 21, 2015 |
| K050812 | mesa laboratories | 90XL INSTRUMENTATION SYSTEM | May 5, 2005 |
| K020909 | ibp instruments | HDM99 | May 22, 2002 |
| K020908 | ibp instruments | HDM97 | May 22, 2002 |
| K992431 | automata instrumentation | NEO-2 METER | October 13, 1999 |
| K981294 | automata instrumentation | ODYSSEY INSTRUMENTATION SYSTEM | July 8, 1998 |
| K955298 | automata medical instrumentation | PHOENIX DIALYSATE METER | February 29, 1996 |
| K920810 | automata medical instrumentation | NEO-STAT DIALYSATE METER | January 15, 1993 |
| K881098 | automata | MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER | April 21, 1988 |
| K871708 | automata | NEO-I TEMPERATURE & CONDUCTIVITY METER | June 17, 1987 |
| K853735 | colorado medical | COLORADO MEDICAL MODEL CTM-3000 | October 4, 1985 |
| K780932 | western laboratories | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT | August 31, 1978 |