SOLAR GI— 510(k) K121014
Substantially EquivalentMedical Measurement Systems B.V.
FDA 510(k) clearance K121014 for SOLAR GI, Substantially Equivalent on 2012-08-01. Applicant: Medical Measurement Systems B.V.. Device class: 2.
Clearance details
- Applicant
- Medical Measurement Systems B.V.
- Product code
- Code FFX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1725
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Enschede Overijssel, NL
Recent devices under product code FFX
view allMore clearances from Medical Measurement Systems B.V.
view allAdverse events under product code FFX
product code FFX- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K121014
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121014.
Data sourced from openFDA. This site is unofficial and independent of the FDA.