KRC · Tester, Electrode, Surface, Electrocardiographic
Cardiovascular · 21 CFR 870.2370 · Class 2
Overview
| Product Code | KRC |
|---|---|
| Device Name | Tester, Electrode, Surface, Electrocardiographic |
| Regulation | 21 CFR 870.2370 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
An electrocardiograph surface electrode tester is a device used to test the function and application of electrocardiograph electrodes.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023713 | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 | Sontra Medical, Inc. | Jan 28, 2004 | SESE |
| K872370 | BIOMA 3500 | E.B.S., Inc. | Dec 7, 1987 | SESE |
| K874327 | SKIN PREP ANALYZER | Marquette Electronics, Inc. | Nov 23, 1987 | SESE |
| K874155 | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | Circadian, Inc. | Nov 23, 1987 | SESE |
| K840358 | IMPEDANCE/8200 MONITOR-MODEL 8300 | Aequitron Medical, Inc. | Oct 30, 1984 | SESE |
| K833619 | CONDUCTANCE METER | Circadian, Inc. | Jan 27, 1984 | SESE |
| K830876 | PREP-CHECK | General Devices | May 18, 1983 | SESE |
| K830823 | Z VIEW METER MODEL 300 | Lintronics Industries, Inc. | May 18, 1983 | SESE |
| K813358 | GERARD MEDICAL ELECTRODE TESTER | Gerard Medical Enterprises, Inc. | Dec 29, 1981 | SESE |
| K780501 | ELECTRODE TESTER | Mg Medical Electronics | May 19, 1978 | SESE |
| K771014 | TS-100 TEST SYSTEM | Delta Medical Industries | Jun 14, 1977 | SESE |
Top Applicants
- Circadian, Inc. — 2 clearances
- Aequitron Medical, Inc. — 1 clearance
- Delta Medical Industries — 1 clearance
- E.B.S., Inc. — 1 clearance
- General Devices — 1 clearance
