21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)— 510(k) K063197
Substantially EquivalentTotoku Electric Co., Ltd.
FDA 510(k) clearance K063197 for 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2), Substantially Equivalent on 2006-11-30. 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
- Traditional
- Location
- Ueda, JP
Recent devices under product code LLZ
view allMore clearances from Totoku Electric Co., Ltd.
view all- K113443 — 21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
- K113136 — 21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
- K112145 — MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2
- K112604 — 21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)
- K111496 — 21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
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.