Solar Gi System
FDA 510(k) K031084 · Medical Measurement Systems B.V.
510(k) numberK031084
Submission
- Device name
- Solar Gi System
- Applicant
- Medical Measurement Systems B.V.
Enschede Overijssel, NL - Received
- April 4, 2003
- Decision date
- March 19, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FFX – System, Gastrointestinal Motility (Electrical)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1725
- Specialty
- Gastroenterology, Urology
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More from Crospon, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K121014 | Solar GiFFX · Traditional | 08/01/2012SE |
| K071094 | Modification to Solar GiFFX · Traditional | 08/13/2007SE |
| K060166 | OhmegaFFX · Traditional | 04/21/2006SE |
| K052338 | Solar GiFFX · Special | 12/15/2005SE |
| K050993 | MMS Video OptionLLZ · Traditional | 05/26/2005SE |
| K031930 | High Speed Emg ModuleGWF · Traditional | 03/03/2004SE |
Questions and answers
When was Solar Gi System cleared by the FDA?
Solar Gi System (K031084) received a 510(k) decision of Substantially Equivalent on March 19, 2004, 350 days after the submission was received.
What is the product code of K031084?
The FDA product code is FFX – System, Gastrointestinal Motility (Electrical), a Class II (moderate risk) device regulated under 21 CFR 876.1725.