ARGUS PB-3000— 510(k) K221056

Substantially Equivalent

Schiller AG

FDA 510(k) clearance K221056 for ARGUS PB-3000, Substantially Equivalent on 2023-07-06. Applicant: Schiller AG.

Clearance details

Applicant: Schiller AG
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2022-04-11
Decision date: 2023-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baar, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.