FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
SOLAR GI
K Number: K052338
·
Decision Dec 15, 2005
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
68
Applicant Total
7
Review Days
111
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Basic Information
- Device Name
- SOLAR GI
- K Number
- K052338
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1725
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Measurement Systems B.V.
- Date Received
- August 26, 2005
- Decision Date
- December 15, 2005
- 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 Medical Measurement Systems B.V.
| K Number | Device Name | ||
|---|---|---|---|
| K121014 | SOLAR GI | Aug 1, 2012 | Substantially Equivalent |
| K071094 | MODIFICATION TO SOLAR GI | Aug 13, 2007 | Substantially Equivalent |
| K060166 | OHMEGA | Apr 21, 2006 | Substantially Equivalent |
| K050993 | MMS VIDEO OPTION | May 26, 2005 | Substantially Equivalent |
| K031084 | SOLAR GI SYSTEM | Mar 19, 2004 | Substantially Equivalent |
| K031930 | HIGH SPEED EMG MODULE | Mar 3, 2004 | Substantially Equivalent |