KRC — Tester, Electrode, Surface, Electrocardiographic Class II
FDA product code KRC covers "Tester, Electrode, Surface, Electrocardiographic", a Class II medical device regulated under 21 CFR 870.2370. Submissions are reviewed by the Cardiovascular panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KRC
- Device Class
- Class II
- Regulation Number
- 870.2370
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K023713 | sontra medical | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 | January 28, 2004 |
| K872370 | e.b.s | BIOMA 3500 | December 7, 1987 |
| K874327 | marquette electronics | SKIN PREP ANALYZER | November 23, 1987 |
| K874155 | circadian | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | November 23, 1987 |
| K840358 | aequitron medical | IMPEDANCE/8200 MONITOR-MODEL 8300 | October 30, 1984 |
| K833619 | circadian | CONDUCTANCE METER | January 27, 1984 |
| K830876 | general devices | PREP-CHECK | May 18, 1983 |
| K830823 | lintronics industries | Z VIEW METER MODEL 300 | May 18, 1983 |
| K813358 | gerard medical enterprises | GERARD MEDICAL ELECTRODE TESTER | December 29, 1981 |
| K780501 | mg medical electronics | ELECTRODE TESTER | May 19, 1978 |
| K771014 | delta medical industries | TS-100 TEST SYSTEM | June 14, 1977 |