Dantec Electronics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 12
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | June 18, 1990 |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | May 14, 1990 |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | October 4, 1989 |
| K881915 | DANTEC MAGNETIC STIMULATOR | October 17, 1988 |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | April 14, 1988 |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | April 14, 1988 |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | January 22, 1988 |
| K870567 | EVOPORT 300 | October 6, 1987 |
| K872106 | DANTEC COUNTERPOINT | September 10, 1987 |
| K860368 | URDYN 5000 (UROFLOWMETER) | April 23, 1986 |
| K853119 | URODYN 1000 | October 4, 1985 |
| K843815 | EVOMATIC 8000/4000 | May 31, 1985 |