Tester, Electrode, Surface, Electrocardiographic
FDA product code KRC · Class II (moderate risk) · 21 CFR 870.2370 · Cardiovascular
11510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023713 | Sonoprep Impedance Diagnostics (Idx) System, Model D1000KRC · Traditional | Sontra Medical, Inc. | 01/28/2004SE |
| K872370 | Bioma 3500KRC · Traditional | E.B.S., Inc. | 12/07/1987SE |
| K874327 | Skin Prep AnalyzerKRC · Traditional | Marquette Electronics, Inc. | 11/23/1987SE |
| K874155 | Circamed Monitor Remote Start Conductance MeterKRC · Traditional | Circadian, Inc. | 11/23/1987SE |
| K840358 | IMPEDANCE/8200 Monitor-Model 8300KRC · Traditional | Aequitron Medical, Inc. | 10/30/1984SE |
| K833619 | Conductance MeterKRC · Traditional | Circadian, Inc. | 01/27/1984SE |
| K830876 | Prep-CheckKRC · Traditional | General Devices | 05/18/1983SE |
| K830823 | Z View Meter Model 300KRC · Traditional | Lintronics Industries, Inc. | 05/18/1983SE |
| K813358 | Gerard Medical Electrode TesterKRC · Traditional | Gerard Medical Enterprises, Inc. | 12/29/1981SE |
| K780501 | Electrode TesterKRC · Traditional | Mg Medical Electronics | 05/19/1978SE |
| K771014 | TS-100 Test SystemKRC · Traditional | Delta Medical Industries | 06/14/1977SE |