KRC
11 FDA 510(k) clearances · Product code
61 daysmedian time to decision
278 days90th percentile
11clearances measured
FDA profile
- Official device name
- Tester, Electrode, Surface, Electrocardiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2370
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 (K023713) | Sontra Medical, Inc. | 2004-01-28 |
| BIOMA 3500 (K872370) | E.B.S., Inc. | 1987-12-07 |
| CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (K874155) | Circadian, Inc. | 1987-11-23 |
| SKIN PREP ANALYZER (K874327) | Marquette Electronics, Inc. | 1987-11-23 |
| IMPEDANCE/8200 MONITOR-MODEL 8300 (K840358) | Aequitron Medical, Inc. | 1984-10-30 |
| CONDUCTANCE METER (K833619) | Circadian, Inc. | 1984-01-27 |
| PREP-CHECK (K830876) | General Devices | 1983-05-18 |
| Z VIEW METER MODEL 300 (K830823) | Lintronics Industries, Inc. | 1983-05-18 |
| GERARD MEDICAL ELECTRODE TESTER (K813358) | Gerard Medical Enterprises, Inc. | 1981-12-29 |
| ELECTRODE TESTER (K780501) | Mg Medical Electronics | 1978-05-19 |
| TS-100 TEST SYSTEM (K771014) | Delta Medical Industries | 1977-06-14 |
Track KRC automatically
Every clearance here is in the API, with alerts when new ones post.