DSM — Alarm, Leakage Current, Portable Class I
FDA product code DSM covers "Alarm, Leakage Current, Portable", a Class I medical device regulated under 21 CFR 870.2640. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- DSM
- Device Class
- Class I
- Regulation Number
- 870.2640
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K781152 | cardio-dynamics laboratories | ELECTROCARDIOGRAPHIC ECG RECORDER | August 31, 1978 |