FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ELPHA 2000 CONTI
K Number: K964738
·
Decision Aug 14, 1997
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
95
Applicant Total
6
Review Days
274
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Basic Information
- Device Name
- ELPHA 2000 CONTI
- K Number
- K964738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5320
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dan Med, Inc.
- Date Received
- November 13, 1996
- Decision Date
- August 14, 1997
- Product Code
- KPI
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Dan Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K013210 | TRUWAVE | Apr 4, 2002 | Substantially Equivalent |
| K012885 | NEUROMOVE NM900 | Nov 8, 2001 | Substantially Equivalent |
| K010745 | EMS 3000 | Jun 27, 2001 | Substantially Equivalent |
| K991241 | IF8000 | Nov 2, 1999 | Substantially Equivalent |
| K972997 | AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION | Nov 10, 1997 | Substantially Equivalent |