Tester, Electrode, Surface, Electrocardiographic
This device is a surface electrocardiographic electrode tester used to evaluate the impedance, adhesion, and electrical performance of ECG electrodes before or during use, ensuring reliable cardiac monitoring signal quality. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KRC, regulated under 21 CFR 870.2370 within the Cardiovascular specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- KRC
- Device Class
- FDA class 2
- Regulation Number
- 870.2370
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023713 | SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 | Jan 28, 2004 | Substantially Equivalent | Sontra Medical, Inc. |
| K872370 | BIOMA 3500 | Dec 07, 1987 | Substantially Equivalent | E.B.S., Inc. |
| K874327 | SKIN PREP ANALYZER | Nov 23, 1987 | Substantially Equivalent | Marquette Electronics, Inc. |
| K874155 | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER | Nov 23, 1987 | Substantially Equivalent | Circadian, Inc. |
| K840358 | IMPEDANCE/8200 MONITOR-MODEL 8300 | Oct 30, 1984 | Substantially Equivalent | Aequitron Medical, Inc. |
| K833619 | CONDUCTANCE METER | Jan 27, 1984 | Substantially Equivalent | Circadian, Inc. |
| K830876 | PREP-CHECK | May 18, 1983 | Substantially Equivalent | General Devices |
| K830823 | Z VIEW METER MODEL 300 | May 18, 1983 | Substantially Equivalent | Lintronics Industries, Inc. |
| K813358 | GERARD MEDICAL ELECTRODE TESTER | Dec 29, 1981 | Substantially Equivalent | Gerard Medical Enterprises, Inc. |
| K780501 | ELECTRODE TESTER | May 19, 1978 | Substantially Equivalent | Mg Medical Electronics |
| K771014 | TS-100 TEST SYSTEM | Jun 14, 1977 | Substantially Equivalent | Delta Medical Industries |
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.