21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)— 510(k) K133181

Substantially Equivalent

Jvckenwood Corporation

FDA 510(k) clearance K133181 for 21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258), Substantially Equivalent on 2013-12-03. Applicant: Jvckenwood Corporation. Device class: 2.

Clearance details

Applicant
Jvckenwood Corporation
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
Yokohama-Shi, Kanagawa, JP
Download summary PDFView on FDA.gov ↗

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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.