UFIT TEN-10— 510(k) K122443

Substantially Equivalent

Biosign Technologies, Inc.

FDA 510(k) clearance K122443 for UFIT TEN-10, Substantially Equivalent on 2012-11-20. Applicant: Biosign Technologies, Inc..

Clearance details

Applicant: Biosign Technologies, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2012-08-10
Decision date: 2012-11-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Indianpolis, IN, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.