Alarm, Leakage Current, Portable
The Portable Leakage Current Alarm is a cardiovascular electrical safety device used to detect and alert staff to dangerous levels of leakage current in medical electrical equipment, protecting patients and personnel from electrical hazards in clinical environments. It is classified as an FDA Class 1 device, representing the lowest level of regulatory concern, and is subject to general controls only. The product code is DSM and it is regulated under 21 CFR 870.2640 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DSM
- Device Class
- FDA class 1
- Regulation Number
- 870.2640
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K781152 | ELECTROCARDIOGRAPHIC ECG RECORDER | Aug 31, 1978 | Substantially Equivalent | Cardio-Dynamics Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.