THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777— 510(k) K051861
Substantially EquivalentSavion Industries, Ltd.
FDA 510(k) clearance K051861 for THE SAVION INDUSTRIES MEDI-CRUISER MODEL MS777, Substantially Equivalent on 2005-09-28. Applicant: Savion Industries, Ltd..
Clearance details
- Applicant
- Savion Industries, Ltd.
- Product code
- Code INK
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ashdod, IL
Adverse events under product code INK
product code INK- Malfunction
- 708
- Other
- 1
- Total
- 709
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.