FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
K Number: K120524
·
Decision Jun 21, 2012
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
4
Review Days
120
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Basic Information
- Device Name
- SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM
- K Number
- K120524
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mui Scientific
- Date Received
- February 22, 2012
- Decision Date
- June 21, 2012
- 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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