OMIBAND— 510(k) K904445

Substantially Equivalent

Omikron Scientific, Ltd.

FDA 510(k) clearance K904445 for OMIBAND, Substantially Equivalent on 1991-03-06. Applicant: Omikron Scientific, Ltd..

Clearance details

Applicant: Omikron Scientific, Ltd.
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1990-09-28
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot-76120, IL

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.