MI-750 PROCEDURAL/MINOR SURGICAL LIGHT— 510(k) K140812
Substantially EquivalentMedical Illumination International, Inc.
FDA 510(k) clearance K140812 for MI-750 PROCEDURAL/MINOR SURGICAL LIGHT, Substantially Equivalent on 2014-08-07. Applicant: Medical Illumination International, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Illumination International, Inc.
- Product code
- Code FSY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4580
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Fernando, CA, US
Recent devices under product code FSY
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Adverse events under product code FSY
product code FSY- Malfunction
- 2,759
- Other
- 1
- Total
- 2,760
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.