5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)— 510(k) K041737
Substantially EquivalentTotoku Electric Co., Ltd.
FDA 510(k) clearance K041737 for 5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A), Substantially Equivalent on 2004-07-13. Applicant: Totoku Electric Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Totoku Electric Co., Ltd.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ueda, JP
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Adverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.