FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
K Number: K003580
·
Decision Jul 31, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
2
Review Days
253
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Basic Information
- Device Name
- UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER
- K Number
- K003580
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unisensor AG
- Date Received
- November 20, 2000
- Decision Date
- July 31, 2001
- Product Code
- FFX
- 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Unisensor AG
| K Number | Device Name | ||
|---|---|---|---|
| K062222 | UNITIP HIGH RESOLUTION CATHETER | Mar 15, 2007 | Substantially Equivalent |