Diagnostic Monitoring Software
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133014 | DMS 300-2W HOLTER ECG RECORDER | May 19, 2014 |
| K062959 | DMS 300-2, 300-3 AND 300-4 | October 16, 2006 |
| K062088 | PREMIER 11 HOLTER | August 25, 2006 |
| K062007 | DMS 300-7 | August 16, 2006 |
| K911615 | HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 | January 8, 1992 |