UNISIGHT SYSTEM WITH UNIGATE— 510(k) K023394

Substantially Equivalent

Electronic Business Machine Co., Ltd. (Ebm)

FDA 510(k) clearance K023394 for UNISIGHT SYSTEM WITH UNIGATE, Substantially Equivalent on 2003-01-07. Applicant: Electronic Business Machine Co., Ltd. (Ebm).

Clearance details

Applicant: Electronic Business Machine Co., Ltd. (Ebm)
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2002-10-09
Decision date: 2003-01-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Honolulu, HI, US

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Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.