Meter, Conductivity, Non-Remote
FDA product code FIZ · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology
13510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201765 | SmartHDM-510 SystemFIZ · Special | Mesa Laboratories, Inc. | 09/02/2020SE |
| K150657 | Phoenix XL Dialysate MeterFIZ · Traditional | Mesa Laboratories, Inc. | 09/21/2015SE |
| K050812 | 90XL Instrumentation SystemFIZ · Special | Mesa Laboratories, Inc. | 05/05/2005SE |
| K020909 | HDM99FIZ · Traditional | Ibp Instruments GmbH | 05/22/2002SE |
| K020908 | HDM97FIZ · Traditional | Ibp Instruments GmbH | 05/22/2002SE |
| K992431 | NEO-2 MeterFIZ · Traditional | Automata Instrumentation, Inc. | 10/13/1999SE |
| K981294 | Odyssey Instrumentation SystemFIZ · Traditional | Automata Instrumentation, Inc. | 07/08/1998SE |
| K955298 | Phoenix Dialysate MeterFIZ · Traditional | Automata Medical Instrumentation, Inc. | 02/29/1996SE |
| K920810 | Neo-Stat Dialysate MeterFIZ · Traditional | Automata Medical Instrumentation, Inc. | 01/15/1993SE |
| K881098 | Modified Neo-I Temperature, Conductivity MeterFIZ · Traditional | Automata, Inc. | 04/21/1988SE |
| K871708 | Neo-I Temperature & Conductivity MeterFIZ · Traditional | Automata, Inc. | 06/17/1987SE |
| K853735 | Colorado Medical Model CTM-3000FIZ · Traditional | Colorado Medical, Inc. | 10/04/1985SE |
| K780932 | Model 80 Conductivity/Temp.Test UnitFIZ · Traditional | Western Laboratories Corp. | 08/31/1978SE |