PACENTRIC CONNECT, TRAVELER AND WEB— 510(k) K100837

Substantially Equivalent

Fimreite Software AS

FDA 510(k) clearance K100837 for PACENTRIC CONNECT, TRAVELER AND WEB, Substantially Equivalent on 2010-12-03. Applicant: Fimreite Software AS.

Clearance details

Applicant: Fimreite Software AS
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-03-24
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Horten, NO

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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.