510(k) K072466— STATIM 7000 (WITHOUT USB PORT), MODEL 01-702100, STATIM 7000 (WITH USB PORT), MODEL 01-702101

Substantially Equivalent

Scican , Ltd.

Clearance details

Applicant: Scican , Ltd.
Product code: Code FLE
Advisory panel: General Hospital
Date received: 2007-09-04
Decision date: 2007-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

Adverse events under product code FLE

product code FLE

Malfunction: 444
Total: 444

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.