FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANTEC COUNTERPOINT
K Number: K872106
·
Decision Sep 10, 1987
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
137
Applicant Total
12
Review Days
101
Basic Information
- Device Name
- DANTEC COUNTERPOINT
- K Number
- K872106
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1870
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- DANTEC ELECTRONICS, INC.
- Date Received
- June 1, 1987
- Decision Date
- September 10, 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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|---|---|---|---|
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| K881915 | DANTEC MAGNETIC STIMULATOR | Oct 17, 1988 | Substantially Equivalent |
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| K874759 | 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE | Apr 14, 1988 | Substantially Equivalent |
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| K870567 | EVOPORT 300 | Oct 6, 1987 | Substantially Equivalent |
| K860368 | URDYN 5000 (UROFLOWMETER) | Apr 23, 1986 | Substantially Equivalent |
| K853119 | URODYN 1000 | Oct 4, 1985 | Substantially Equivalent |