510(k) K780501
- Device
- Electrode Tester
- Applicant
- MG MEDICAL ELECTRONICS
- 510(k) number
- K780501
- Product code
- KRC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-05-19
- Date received
- 1978-03-28
- Regulation
- 870.2370
- Classification name
- Tester, Electrode, Surface, Electrocardiographic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007603826
- 3013500228
- 3000126629
- 3012528160
- 3009156722
- 3013596024
- 9610816
- 2221819
- 3009077524
- 3003263092
- 3016701404
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KRC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023713 | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 | Sontra Medical, Inc. | 2004-01-28 |
| K872370 | BIOMA 3500 | E.B.S., Inc. | 1987-12-07 |
| K874155 | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | Circadian, Inc. | 1987-11-23 |
| K874327 | SKIN PREP ANALYZER | Marquette Electronics, Inc. | 1987-11-23 |
| K840358 | IMPEDANCE/8200 MONITOR-MODEL 8300 | Aequitron Medical, Inc. | 1984-10-30 |
| K833619 | CONDUCTANCE METER | Circadian, Inc. | 1984-01-27 |
| K830823 | Z VIEW METER MODEL 300 | Lintronics Industries, Inc. | 1983-05-18 |
| K830876 | PREP-CHECK | General Devices | 1983-05-18 |
| K813358 | GERARD MEDICAL ELECTRODE TESTER | Gerard Medical Enterprises, Inc. | 1981-12-29 |
| K771014 | TS-100 TEST SYSTEM | Delta Medical Industries | 1977-06-14 |