FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOPORT 300
K Number: K870567
·
Decision Oct 6, 1987
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
138
Applicant Total
12
Review Days
238
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Basic Information
- Device Name
- EVOPORT 300
- K Number
- K870567
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Dantec Electronics, Inc.
- Date Received
- February 10, 1987
- Decision Date
- October 6, 1987
- Product Code
- GWF
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Dantec Electronics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895460 | CONCENTRIC ELECTRODE TYPE #13R01, 13R02 | Jun 18, 1990 | Substantially Equivalent |
| K894911 | SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 | May 14, 1990 | Substantially Equivalent |
| K884915 | DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER | Oct 4, 1989 | Substantially Equivalent |
| K881915 | DANTEC MAGNETIC STIMULATOR | Oct 17, 1988 | Substantially Equivalent |
| K874758 | DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE | Apr 14, 1988 | Substantially Equivalent |
| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | Apr 14, 1988 | Substantially Equivalent |
| K874735 | DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE | Jan 22, 1988 | Substantially Equivalent |
| K872106 | DANTEC COUNTERPOINT | Sep 10, 1987 | Substantially Equivalent |
| K860368 | URDYN 5000 (UROFLOWMETER) | Apr 23, 1986 | Substantially Equivalent |
| K853119 | URODYN 1000 | Oct 4, 1985 | Substantially Equivalent |