NON-INVASIVE INFRARED (NIR)— 510(k) K090386

Substantially Equivalent

Medisim, Ltd.

FDA 510(k) clearance K090386 for NON-INVASIVE INFRARED (NIR), Substantially Equivalent on 2010-05-28. Applicant: Medisim, Ltd..

Clearance details

Applicant: Medisim, Ltd.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2009-02-17
Decision date: 2010-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neve Ilan, IL

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.