Panels › Gastroenterology, Urology › Product code FIZ · Class 2
Meter, Conductivity, Non-Remote
Regulation 876.5820
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FIZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Mesa Laboratories, Inc. | 3 | 0 |
| Automata, Inc. | 2 | 0 |
| Automata Instrumentation, Inc. | 2 | 0 |
| Automata Medical Instrumentation, Inc. | 2 | 0 |
| Ibp Instruments GmbH | 2 | 0 |
| Colorado Medical, Inc. | 1 | 0 |
| Western Laboratories Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 2020 | K201765 | SmartHDM-510 System Mesa Laboratories, Inc. | FIZ |
| Sep 21, 2015 | K150657 | Phoenix XL Dialysate Meter Mesa Laboratories, Inc. | FIZ |
| May 5, 2005 | K050812 | 90XL INSTRUMENTATION SYSTEM Mesa Laboratories, Inc. | FIZ |
| May 22, 2002 | K020909 | HDM99 Ibp Instruments GmbH, DE | FIZ |
| May 22, 2002 | K020908 | HDM97 Ibp Instruments GmbH, DE | FIZ |
| Oct 13, 1999 | K992431 | NEO-2 METER Automata Instrumentation, Inc. | FIZ |
| Jul 8, 1998 | K981294 | ODYSSEY INSTRUMENTATION SYSTEM Automata Instrumentation, Inc. | FIZ |
| Feb 29, 1996 | K955298 | PHOENIX DIALYSATE METER Automata Medical Instrumentation, Inc. | FIZ |
| Jan 15, 1993 | K920810 | NEO-STAT DIALYSATE METER Automata Medical Instrumentation, Inc. | FIZ |
| Apr 21, 1988 | K881098 | MODIFIED NEO-I TEMPERATURE, CONDUCTIVITY METER Automata, Inc. | FIZ |
| Jun 17, 1987 | K871708 | NEO-I TEMPERATURE & CONDUCTIVITY METER Automata, Inc. | FIZ |
| Oct 4, 1985 | K853735 | COLORADO MEDICAL MODEL CTM-3000 Colorado Medical, Inc. | FIZ |
| Aug 31, 1978 | K780932 | MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT Western Laboratories Corp. | FIZ |
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