DSM · Alarm, Leakage Current, Portable
Cardiovascular · 21 CFR 870.2640 · Class 1
Overview
| Product Code | DSM |
|---|---|
| Device Name | Alarm, Leakage Current, Portable |
| Regulation | 21 CFR 870.2640 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A portable leakage current alarm is a device used to measure the electrical leakage current between any two points of an electrical system and to sound an alarm if the current exceeds a certain threshold.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K781152 | ELECTROCARDIOGRAPHIC ECG RECORDER | Cardio-Dynamics Laboratories, Inc. | Aug 31, 1978 | SESE |
Top Applicants
- Cardio-Dynamics Laboratories, Inc. — 1 clearance
