GEM HEART ONE/ONE+— 510(k) K092576

Substantially Equivalent

Gem-Med S.L.

FDA 510(k) clearance K092576 for GEM HEART ONE/ONE+, Substantially Equivalent on 2009-09-04. Applicant: Gem-Med S.L..

Clearance details

Applicant: Gem-Med S.L.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2009-08-21
Decision date: 2009-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.